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Getting Started
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Learning Catalogs
Available catalogs can be accessed here to get you started on your learning journey.
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Overview of Complaints
So you got your device to market. Now what? Well one of the major things to be ready for now are complaints. This course will help you understand what is required and share some best practices.
0 hr 17 min
CAPA
FDA
Feedback
Complaints
Initial QMS Procedures
QMS Refinement & Regulatory Submissions
Product Launch
Post-Market Surveillance
Advance Exclusive
Course
Fireside Chat with a MedTech Living Legend
Limited Availability
1 hr 2 min
Advance Exclusive
Webinar
Future of Quality Panel
MedTech leaders answer questions and discuss the future of quality in the medical device industry. Hear what the experts think is just on the horizon!
Currently Unavailable
0 hr 29 min
Quality Management
Advance Exclusive
Webinar
Implementation of Risk Management Board for New Product Introduction and PMS
Limited Availability
0 hr 56 min
Risk Management
Advance Exclusive
Webinar
Basil Akra: Status of EU MDR and EU IVDR
0 hr 40 min
EU MDR
IVDR
Advance Exclusive
Webinar
Building the Business Case
Learn why it's important to be able to articulate your business plan and some best practices specific to the medical device industry.
Currently Unavailable
0 hr 20 min
Ideation & Prototyping
QMS Refinement & Regulatory Submissions
Advance Exclusive
Webinar
Product Development and Engineering Checkpoint Alpha
We are so excited you are on this journey with us! Unlock this course after completing Path 1 from the Product Development and Engineering collection and earn your Specialist Badge.
Currently Unavailable
Advance Exclusive
Regulatory Pathways Round Table
Limited Availability
0 hr 32 min
EU MDR
IVDR
ISO 13485
FDA
Regulatory Management
QMS Refinement & Regulatory Submissions
Advance Exclusive
Webinar
Building Companies and Careers: Your Brand
Currently Unavailable
0 hr 41 min
Advance Exclusive
Webinar
Quality Spotlight: Trials & Triumphs of Complaint Handling
Complaints are a crucial part of every medical device's lifecycle. Join this experienced panel to discuss what works, what doesn't, and other notable experiences surrounding this topic.
Limited Availability
1 hr 2 min
Complaints
Quality Management
Initial QMS Procedures
QMS Refinement & Regulatory Submissions
Product Launch
Post-Market Surveillance
Advance Exclusive
Webinar
The Art of Defining Design Inputs and Design Outputs
The art of defining design inputs & design outputs for FDA compliance by medical device manufacturers.
Currently Unavailable
Design Controls
QMS
Product Development
Advance Exclusive
eBook
The Ultimate Guide to CAPA
This guide will provide you with best practices and ways to improve your CAPA process and approach so that you can ultimately ensure the medical devices you design, develop, manufacture, and sell will be as safe and effective as possible for those patients that depend upon them.
Currently Unavailable
CAPA
QMS
Product Launch
Post-Market Surveillance
Advance Exclusive
eBook
Audit Basics
Learn the difference between audits, inspections, and the different types of each you may encounter in the medical device industry.
0 hr 42 min
Audit
EU MDR
ISO 13485
FDA
Initial QMS Procedures
QMS Refinement & Regulatory Submissions
Product Launch
Post-Market Surveillance
Course
Quality Assurance Management Checkpoint Alpha
We are so excited you are on this journey with us! Unlock this course after completing Path 1 from the collection and earn your Specialist Badge.
Currently Unavailable
Advance Exclusive
Regulatory Affairs for Medical Devices (Level 3)
The third level of this RA learning path is ready for you! Are you ready to take your knowledge to the next level?
Limited Availability
13 Courses
Risk Management
EU MDR
IVDR
ISO 14971
UDI
cybersecurity
Usability Engineering
Regulatory Management
Advance Exclusive
An Overview of UDI Requirements for MedTech
Gain a high level understanding of UDI requirements and some insight into keeping up in the future.
30 min
EU MDR
FDA
UDI
Quality Management
Regulatory Management
QMS Refinement & Regulatory Submissions
Course
Managing Risks Along an IVD-Analyzer's Life-Cycle
A session by Christopher Schar, Senior Consultant with QUNIQUE
Currently Unavailable
0 hr 44 min
Advance Exclusive
Webinar
How and When to Conduct your First Hazard Analysis
A session by Sarah Nixon, Quality Engineer with Rook Quality Systems
Currently Unavailable
0 hr 45 min
Ideation & Prototyping
Product Development
Advance Exclusive
Webinar
Mindset Tools for High Performance Teams
Currently Unavailable
0 hr 31 min
Advance Exclusive
Webinar
CAPA Report Template for the Medical Device Industry
Use this template to complete your CAPA reports as a part of your QMS
CAPA
Audit
QMS
Template
Product Launch
Post-Market Surveillance
Advance Exclusive
Building a Regulatory Strategy
Your Regulatory Strategy is a lot more than just jumping through "regulatory hoops". It's your strategic pathway to getting a safe and effective device to market. It could even help you get funding if you have a solid foundation to show potential investors. Let's learn more in this course.
1 hr 14 min
Regulatory Management
Initial QMS Procedures
QMS Refinement & Regulatory Submissions
Advance Exclusive
Webinar
Nonconformance Report Template
Use this template to document nonconformance in your QMS.
Limited Availability
Audit
QMS
Template
Product Launch
Post-Market Surveillance
Advance Exclusive
The Basics of Cybersecurity for Medical Device Manufacturers
Why is cybersecurity such a hot topic in MedTech spaces right now? Learn the basics in this self-paced, interactive course.
0 hr 32 min
EU MDR
FDA
cybersecurity
Product Development
Post-Market Surveillance
Advance Exclusive
Course
Product Development and Engineering Checkpoint Charlie
You've gone from a Specialist to an Authority and you aren't done yet! Complete the courses in Level 3 and visit this checkpoint to get your Expert badge!
Currently Unavailable
Advance Exclusive
CE Mark Technical Documentation: Changes, Application, and Notified Body Expectations under MDR
This presentation will provide an overview of the technical documentation requirements under MDR including format and content.
0 hr 54 min
Initial QMS Procedures
Product Development
QMS Refinement & Regulatory Submissions
Advance Exclusive
Webinar
MedTech Cybersecurity Panel
Limited Availability
0 hr 40 min
cybersecurity
Advance Exclusive
Webinar
The Importance of Design Controls
It's important to know what benefits and advantages good design control processes will lead to. This course will go beyond the regulation to help shed light on why we should care about design controls.
0 hr 32 min
Design Controls
FDA
Product Development
Advance Exclusive
Course
Risk Management Plan Template
Plan your approach to risk within your quality management system with this helpful template to get you started.
Limited Availability
Risk Management
Template
Advance Exclusive
Breakout Session: Incorporating Risk Management throughout your Device Lifecycles
0 hr 40 min
Risk Management
Advance Exclusive
Webinar
Introduction to Quality Management for Medical Devices and ISO 13485
Learn about quality management and the requirements of ISO 13485 during this self-paced, interactive online course.
$350
10 - 15 hours
Risk Management
Document Management
Change Management
Training
ISO 13485
QMS
Quality Management
Regulatory Management
QMS Refinement & Regulatory Submissions
Post-Market Surveillance
Certificate
Course
Premium
$101 - $500
Risk Management in Audits and Inspections
Speakers: John P. Thompson
0 hr 50 min
Standard (Free)
Webinar
Overview of CAPA
The CAPA process is almost always a topic of audits and inspections and regularly one of the top reasons for medical device submissions to be rejected by regulatory bodies. Learn what this process is and why it's so important to creating safer and better medical devices.
0 hr 17 min
CAPA
Initial QMS Procedures
QMS Refinement & Regulatory Submissions
Product Launch
Post-Market Surveillance
Advance Exclusive
Course
15 Steps to Creating a Risk-Based CAPA Process
This PDF and infographic will have you implementing risk in your CAPA process in no time.
Initial QMS Procedures
QMS Refinement & Regulatory Submissions
Product Launch
Post-Market Surveillance
Advance Exclusive
Overview of Nonconformance
This course will help you understand what nonconformance means in the medical device industry, what is required by regulating bodies, and how a well managed nonconformance process will help you make safer and more effective devices.
0 hr 17 min
Nonconformance
Initial QMS Procedures
QMS Refinement & Regulatory Submissions
Product Launch
Post-Market Surveillance
Advance Exclusive
Course
The Journey Continues: What to Know for US FDA Class I and other Global Regulator UDI Requirements
Limited Availability
0 hr 50 min
FDA
UDI
Advance Exclusive
Webinar
Customer Feedback and Complaint Form Template
Use this template to document customer feedback and complaints in your QMS.
Audit
QMS
Template
Product Launch
Post-Market Surveillance
Advance Exclusive
What is the Best Way to Structure a Risk Management File
A session by Carolyn Guthrie, Director QA/RA at Kapstone Medical
Currently Unavailable
0 hr 48 min
Initial QMS Procedures
Product Development
Advance Exclusive
Webinar
Planning your Cloud Connectivity Strategy to Reduce Cybersecurity and Privacy Risk
A session by Abbas Dhilawala, CTO at Galen Data
Currently Unavailable
0 hr 45 min
cybersecurity
Product Development
QMS Refinement & Regulatory Submissions
Advance Exclusive
Webinar
Introduction to Risk Management for Medical Devices and ISO 14971
Learn how to effectively apply risk management principles for medical devices during this self paced, interactive online course.
$350
8 - 16 hours
Quality Management
Regulatory Management
Initial QMS Procedures
Product Development
QMS Refinement & Regulatory Submissions
Product Launch
Post-Market Surveillance
Certificate
Course
Premium
$101 - $500
Applying a Risk-Based Approach to Biological Evaluation of Medical Devices Based on the Framework of ISO 10993-1:2018
What does ISO 10993 require and what are some best practices when applying risk to these evaluations? Learn more from our partner Nelson Labs in this discussion.
0 hr 48 min
Product Development
QMS Refinement & Regulatory Submissions
Advance Exclusive
Webinar
Pre-Market vs. Post Market Risk: What are the similarities and differences?
A session by Mike Drues Ph.D., President at Vascular Sciences
Limited Availability
0 hr 47 min
Risk Management
Product Development
QMS Refinement & Regulatory Submissions
Product Launch
Post-Market Surveillance
Advance Exclusive
Webinar
The Definitive Guide to Responding to FDA 483 and Warning Letters
This guide will go into great detail regarding exactly how to respond to FDA 483 observations and warning letters.
Currently Unavailable
Initial QMS Procedures
QMS Refinement & Regulatory Submissions
Post-Market Surveillance
Advance Exclusive
eBook
The Ultimate Guide to ISO 13485:2016 Quality Management System for Medical Devices
In this guide you'll learn about ISO 13485 and why Greenlight Guru founder Jon Speer believes that a QMS should be a set of processes that help you to run a better, more efficient business that focuses on true quality and what is best for the patients who will be recipients of your medical devices.
Currently Unavailable
ISO 13485
QMS
Initial QMS Procedures
Post-Market Surveillance
Advance Exclusive
eBook
FDA 510(k) Overview
Get to know this common FDA clearance path and understand when you'll need to use it.
0 hr 34 min
510(k)
Initial QMS Procedures
Product Development
QMS Refinement & Regulatory Submissions
Course
A Complete Guide to Bringing a Medical Device to Market
A complete guide for medical device manufacturers looking for guidance on how to plan for a successful product launch and maintain regulatory compliance across global markets.
Risk Management
Design Controls
QMS
Ideation & Prototyping
Initial QMS Procedures
Product Development
QMS Refinement & Regulatory Submissions
Product Launch
Post-Market Surveillance
Advance Exclusive
eBook
This is not your grandmother's validated state!
Limited Availability
0 hr 38 min
Design Controls
Quality Management
Product Development
Advance Exclusive
Webinar
By Design: Reduce Risk and Improve Compliance with a Layered Software Architecture
A session by Cynthia Smith, Senior Medical Project Manager at ICS
Limited Availability
0 hr 47 min
Ideation & Prototyping
Product Development
Advance Exclusive
Webinar
Evaluating need for Biocompatibility Testing & Mitigating Risks when Changing your Medical Device
When you want to know more about biocompatibility, you go to the experts! Hear Thor Rollins of Nelson Labs discuss this crucial topic about the intersection of risk, biocompatibility, and change management.
Currently Unavailable
Risk Management
Change Management
Initial QMS Procedures
Product Development
QMS Refinement & Regulatory Submissions
Advance Exclusive
Webinar
Regulatory Affairs Checkpoint Beta
You're graduating to the level of "Authority". You know your stuff and it's time you got a shiny new badge to prove it. Check-in here and you'll be ready to move on to level 3!
Currently Unavailable
Advance Exclusive
Protecting your Data from Risk: To, From, and In the Cloud
A session by Chris DuPont, CEO at Galen Data
Currently Unavailable
0 hr 45 min
Ideation & Prototyping
Product Development
QMS Refinement & Regulatory Submissions
Product Launch
Post-Market Surveillance
Advance Exclusive
Webinar
Introduction to Clinical Investigation for Medical Devices and ISO 14155
Learn how to optimise the planning and conduct of clinical investigations for medical devices during this self-paced, interactive online course.
$450
10 - 16 hours
Clinical
Certificate
Course
Premium
$101 - $500
CEO Roundtable: Leading Your MedTech Company in 2023 and Beyond
0 hr 37 min
Advance Exclusive
Webinar
An Overview of Human Factors Engineering for MedTech
Usability engineering is so important to medical device safety and efficacy, and we want to share more about this topic with you. This short course will get you started on the path to understanding this crucial skill.
30 min
Usability Engineering
Product Development
Course
Tips for Working with Contract Manufacturing
A session by Eddie Ray, Chief Revenue Officer at Kapstone Medical
Limited Availability
0 hr 49 min
manufacturing
Initial QMS Procedures
Product Development
Product Launch
Post-Market Surveillance
Advance Exclusive
Webinar
Biocompatibility Evaluation for Device Submission
Learn about the requirements for biocompatibility evaluation testing and some best practices from experts in the field.
0 hr 47 min
biocompatibility
Product Development
QMS Refinement & Regulatory Submissions
Advance Exclusive
Webinar
Understanding the Medical Device Single Audit Program (MDSAP): Pros, Cons, and How to Prepare
A session by Angelina Hakim, Owner and CEO at QUNIQUE Group
Limited Availability
0 hr 35 min
Audit
MDSAP
Initial QMS Procedures
Product Launch
Post-Market Surveillance
Advance Exclusive
Webinar
Risk Management for Design Control
Speaker: RCA
0 hr 50 min
Standard (Free)
Webinar
How to Predict Medical Device Recalls using Publicly Available Data
A session by Mohammed (Bilash) Hossain and John Lorenc of Reed Tech
Currently Unavailable
0 hr 45 min
QMS Refinement & Regulatory Submissions
Post-Market Surveillance
Advance Exclusive
Webinar
Regulatory Affairs for Medical Devices (Level 2)
Level 2 of the Regulatory Affairs learning path brings you more important topics and perspectives from industry leaders.
Limited Availability
13 Courses
Risk Management
Change Management
EU MDR
510(k)
FDA
biocompatibility
Regulatory Management
Advance Exclusive
Is your Use-Related Risk Analysis Half Empty or Half Full?
Limited Availability
0 hr 26 min
Risk Management
Advance Exclusive
Webinar
Addressing the Notified Body Bottleneck
This presentation explores the current state of notified body designation and how companies can navigate existing and anticipated scarcity.
0 hr 56 min
Product Development
QMS Refinement & Regulatory Submissions
Advance Exclusive
Webinar
Remote audits
This course will cover remote audits, virtual Inspections, and other alternative tools and methods regulators have implemented, particularly during the Covid 19 pandemic.
0 hr 40 min
Audit
EU MDR
ISO 13485
FDA
Initial QMS Procedures
QMS Refinement & Regulatory Submissions
Product Launch
Post-Market Surveillance
Course
The Ultimate Guide to Design Controls for Medical Device Companies
With this guide, Greenlight Guru founder Jon Speer shares valuable insights to explain what Design Controls are, how to address them, and how they benefit your medical device product development efforts.
Currently Unavailable
Design Controls
ISO 13485
Ideation & Prototyping
Product Development
Advance Exclusive
eBook
Behind the Research: Overcoming the Barriers to Improved Quality
0 hr 46 min
Quality Management
Advance Exclusive
Webinar
An Overview of Risk Management
Learn about risk management for medical devices.
0 hr 28 min
Risk Management
ISO 14971
Ideation & Prototyping
Initial QMS Procedures
Product Development
QMS Refinement & Regulatory Submissions
Product Launch
Standard (Free)
Course
A Step-By-Step Guide to Preparing your FDA 510(k) Submission
Get ready to submit your 510(k) with advice from our industry experts
Document Management
Design Controls
Change Management
Device Classification
QMS
510(k)
Product Development
QMS Refinement & Regulatory Submissions
Advance Exclusive
eBook
Developing a New Clinically Relevant ICU Ventilator Fast
A session by John Walmsley, VP of Strategic Partnerships at Starfish Medical. Learn what the urgent need created by the Covid 19 pandemic can teach us about creating viable medical devices more quickly.
0 hr 37 min
Ideation & Prototyping
Product Development
QMS Refinement & Regulatory Submissions
Product Launch
Post-Market Surveillance
Advance Exclusive
Clinical
Webinar
Quality Assurance Management Checkpoint Charlie
You've gone from a Specialist to an Authority and you aren't done yet! Complete the courses in Level 3 and visit this checkpoint to get your Expert badge!
Currently Unavailable
Advance Exclusive
The Who, What, and When of IVDR Enforcement
A session by Joanne Lebrun, Vice President at MDC Associates Inc.
Currently Unavailable
0 hr 52 min
EU MDR
Post-Market Surveillance
Advance Exclusive
Webinar
The Future of Health and Medicine: Where Can Technology Take Us?
Limited Availability
0 hr 47 min
Advance Exclusive
Webinar
How to Create Medical Device Labels per EU MDR
A session by Monir El Azzouzi, Founder and CEO at Easy Medical Device
Currently Unavailable
0 hr 55 min
Initial QMS Procedures
Product Development
QMS Refinement & Regulatory Submissions
Product Launch
Advance Exclusive
Webinar
The Ins and Outs of Supplier Management
Supplier Management has become such an important topic in 2022. Join this panel to discuss why and how to manage the challenges for medical device developers.
Limited Availability
0 hr 58 min
Supplier Management
Initial QMS Procedures
Product Launch
Post-Market Surveillance
Advance Exclusive
Webinar
Quality Assurance Management Checkpoint Beta
You're graduating to the level of "Authority". You know your stuff and it's time you got a shiny new badge to prove it. Check-in here and you'll be ready to move on to level 3!
Currently Unavailable
Advance Exclusive
Breakout Session: Communicating with the FDA
0 hr 37 min
FDA
Advance Exclusive
Webinar
How to Efficiently Document your Design Transfer to Ace your Audit and Product Launch
A session by Kyle Rose, President at Rook Quality Systems
Limited Availability
0 hr 47 min
Document Management
Design Controls
Product Development
Product Launch
Advance Exclusive
Webinar
The "New" Safety & Performance-Based 510(k)
In this course, we will dive into the intricacies of the Safety & Performance-Based 510(k) (also known as the sp510k) pathway—a newer regulatory avenue that has revolutionized the approval process for medical devices... or has it?
0 hr 22 min
510(k)
FDA
Regulatory Management
QMS Refinement & Regulatory Submissions
The Wait is Over: Assessing the Proposed Rule Aligning FDA's Medical Device Quality System Regulation with ISO 13485:2016
Limited Availability
0 hr 40 min
ISO 13485
QMS
FDA
Regulatory Management
QMS Refinement & Regulatory Submissions
Advance Exclusive
Webinar
An Overview of Design Controls
What are Design Controls? What do the various regulations require in regards to Design Controls? These answers and more are available in this course so let's get started!
0 hr 28 min
Design Controls
ISO 13485
Ideation & Prototyping
Product Development
Course
Internal Audit Checklist
If you want to put your focus on quality rather than just ensuring that your company checks all the regulatory "boxes", then putting the time into effective internal auditing is essential. Here's a free checklist.
Limited Availability
Audit
ISO 13485
QMS
Template
FDA
Initial QMS Procedures
Product Launch
Post-Market Surveillance
Advance Exclusive
Raising Capital for Medical Device Startups
This course offers an insight into what investors are looking for from founders to feel confident investing. This is a great course for early stage founders thinking about raising their first, or next, round of funding.
30 min
Funding
Ideation & Prototyping
Post-Market Surveillance
Course
Perfecting the Pitch: Fundraising Roundtable of Early Stage Investors
About to pitch your device to investors or want to be more prepared next time you do? This panel discussion is for you!
Currently Unavailable
0 hr 49 min
Funding
Ideation & Prototyping
Product Development
Advance Exclusive
Webinar
Risk Management from a Regulatory and Product Development Perspective
Another favorite podcast episode with our frequent guest Mike Drues, Ph.D.
Currently Unavailable
Risk Management
Regulatory Management
Product Development
QMS Refinement & Regulatory Submissions
Advance Exclusive
Podcast
The Basics of Bill of Materials (BOMs) for MedTech
Trust us, these BOMs are perfectly safe as long as you know what you're doing. Join us for a quick look and some best practices in this short course.
30 min
Document Management
QMS
Quality Management
Initial QMS Procedures
Product Development
QMS Refinement & Regulatory Submissions
BOMs
Course
3 Keys to Successful Internal Audits
Gurus Taylor Brown and Sara Adams discuss their top 3 ways to have better internal audits in this quick video
0 hr 4 min
Audit
Initial QMS Procedures
QMS Refinement & Regulatory Submissions
Product Launch
Post-Market Surveillance
Advance Exclusive
Webinar
An Overview of Biocompatibility for Medical Devices
Do all devices need to worry about biocompatibility? What does this topic include anyway? Let's answer these questions and more in this short course.
0 hr 32 min
EU MDR
IVDR
ISO 13485
FDA
biocompatibility
Quality Management
Regulatory Management
Initial QMS Procedures
QMS Refinement & Regulatory Submissions
Course
Regulatory Affairs Checkpoint Delta
What an accomplishment! You spent the time, invested in your own knowledge, and now it's time to celebrate. Now hop in here and get your Guru Badge, so you can show off a little.
Currently Unavailable
Advance Exclusive
Design Controls, Development, and Risk for SaMD
Many elements of medical device development are different for software devices. Learn the key differentiators and best practices for developing these exciting device types.
Risk Management
Design Controls
SAMD
Ideation & Prototyping
Product Development
Advance Exclusive
Podcast
Regulatory Affairs Checkpoint Charlie
You've gone from a Specialist to an Authority and you aren't done yet! Complete the courses in Level 3 and visit this checkpoint to get your Expert badge!
Currently Unavailable
Advance Exclusive
From Self-Declaration to Certification: Proving Performance Under IVDR
Learn best practices around proving performance under the new IVDR requirements.
Currently Unavailable
0 hr 54 min
Product Development
QMS Refinement & Regulatory Submissions
Advance Exclusive
Webinar
Essentials of Software as a Medical Device
With software being a growing industry, in general, it is no surprise that this popularity is making its way to medical devices. This course will give a quick overview of what we mean by Software as a Medical Device as well as what the regulations say about it and how it differs from other medical device development.
$100
0 hr 42 min
SAMD
Initial QMS Procedures
Product Development
QMS Refinement & Regulatory Submissions
Software
Cybersecurity
Course
Introduction to Working in the Medical Device Industry
Prepare yourself for working in the medical device industry with this introductory, self-paced online course.
$100
3 - 6 hours
Document Management
Design Controls
Audit
EU MDR
Device Classification
QMS
FDA
Feedback
Quality Management
Regulatory Management
Product Development
Product Launch
Post-Market Surveillance
Certificate
Course
Premium
What is a Medical Device?
What actually counts as a medical device? Are there different types of medical devices? How do I begin to know what my regulatory path will be? Get the answers to these questions and more in this course!
0 hr 42 min
EU MDR
ISO 13485
Device Classification
510(k)
FDA
SAMD
Ideation & Prototyping
Course
Change Management and Risk Management: How do we connect the dots and what happens if we don't?
Change management and risk management should work together, but it does take some work to make that happen. Let us help with these important tips and sage advice from Mike Drues.
Risk Management
Change Management
Initial QMS Procedures
Product Development
Product Launch
Post-Market Surveillance
Advance Exclusive
Webinar
Introduction to Project Management for Product Development of Medical Devices
This is a online course that provides a high-level overview as well as hands-on tools and techniques for developing a medical device within budget and schedule constraints. It is a pre-requisite to have good knowledge and experience of design control before starting the course. We also strongly recommend that you take the Introduction to Design Control for Medical Devices online course before this course.
$550
15 - 20 hours
Quality Management
Product Development
QMS Refinement & Regulatory Submissions
Product Launch
Post-Market Surveillance
Certificate
Course
Premium
$501 - $1000
AMA session on MDSAP with Danny Kroo from Docusys
This weeks topic is over the Medical Device Single Audit Program (MDSAP). We hope you enjoy!
Audit
MDSAP
Podcast
Introduction to Safety for Electrical Medical Devices and IEC 60601
Learn how to be effective in electronic medical device safety during this self paced, interactive online course.
$500
10 - 16 hours
Design Controls
EU MDR
FDA
IEC 60601
Initial QMS Procedures
Product Development
QMS Refinement & Regulatory Submissions
Product Launch
Certificate
Course
Premium
$101 - $500
AMA session on Special Controls with Mike Drues from Vascular Sciences
This weeks topic is over the FDA’s “Special Controls with Mike Drues.
FDA
Standard (Free)
Podcast
From Concept to Commercialization: Introduction to Medical Device Development
So you have an idea for a medical device...what now? This course gives a quick overview of the process of developing a medical device and offers a few practical examples from our experiences in the industry.
0 hr 32 min
EU MDR
QMS
FDA
Ideation & Prototyping
Initial QMS Procedures
Product Development
QMS Refinement & Regulatory Submissions
Product Launch
Post-Market Surveillance
Course
Training Management in the Medical Device Industry
Learn what the regulations say about training management and how to best implement it into your QMS in this overview course.
0 hr 28 min
Change Management
Training
ISO 13485
Initial QMS Procedures
Post-Market Surveillance
Standard (Free)
Course
Standards and Pathways to the USA Medical Device Market
Anyone looking to launch a medical device into the United States market should be familiar with the FDA and the regulations they use. This course will give you a look at the regulations themselves and a little history on the FDA and how it came to be.
0 hr 42 min
Device Classification
QMS
510(k)
FDA
Initial QMS Procedures
Product Development
QMS Refinement & Regulatory Submissions
Course
The Entrepreneur's Guide to the Medical Device Industry
$100
13 Courses
Advance Exclusive
Course Package
0-$100
The Risk Management Process and ISO 14971
This course will describe the role of risk management in the industry, explain the framework of the risk process, and define many key terms you'll need to know.
0 hr 32 min
Risk Management
Ideation & Prototyping
Product Development
QMS Refinement & Regulatory Submissions
Product Launch
Advance Exclusive
Course
Regulatory Affairs for Medical Devices (Level 4)
Time for the final path in our Regulatory Affairs series. Get to GURU status with this 4th group of courses.
Limited Availability
12 Courses
Risk Management
EU MDR
IVDR
ISO 14971
FDA
SAMD
UDI
cybersecurity
Regulatory Management
Advance Exclusive
Significant Risk vs. Nonsignificant Risk Devices - What's the Difference?
Check out one of our favorite podcast episodes from the Global Medical Device Podcast with Mike Drues, Ph.D.
Currently Unavailable
Risk Management
Ideation & Prototyping
Initial QMS Procedures
Product Development
QMS Refinement & Regulatory Submissions
Advance Exclusive
Podcast
Standards and Pathways to the EU Medical Device Market
There have been many changes to the process of bringing a medical device to market in the EU. This course will highlight a bit of that history as well as best practices for the current state of the EU MDR.
0 hr 42 min
EU MDR
Device Classification
QMS
Initial QMS Procedures
Product Development
QMS Refinement & Regulatory Submissions
Course
Concept to Commercialization Panel
0 hr 41 min
Advance Exclusive
Webinar
Regulatory Affairs Checkpoint Alpha
We are so excited you are on this journey with us! Unlock this course after completing Path 1 from the collection and earn your Specialist Badge.
Currently Unavailable
Advance Exclusive
Challenges with Applying Risk Management Throughout the Manufacturing Process
Every medical device developer has to understand risk management. You could learn the hard way, or you could listen to our experts share their trials and successes on this important topic.
Risk Management
ISO 14971
manufacturing
Product Development
Product Launch
Post-Market Surveillance
Advance Exclusive
Podcast
Ultimate guide to Agile Design and Development for Medical Devices
In this guide, we discuss how the Agile Method for Medical Device Design is an iterative process that includes all products and product features that are tested, verified and validated, and allows for tweaks, requirement changes, risk updates and compliance updates as needed.
Currently Unavailable
Risk Management
Document Management
Design Controls
Change Management
Ideation & Prototyping
Product Development
Advance Exclusive
eBook
3 Systems of Risk for Medical Devices
Learn about the 3 systems of risk the FDA may use when evaluating your device submission and how you can manage each one.
Risk Management
Ideation & Prototyping
Initial QMS Procedures
Product Development
QMS Refinement & Regulatory Submissions
Advance Exclusive
Podcast
Implementation of the Risk Management Board for New Product Introduction and Post Market Surveillance
A session by Mike Baca, President at White Rook Consulting
Currently Unavailable
0 hr 46 min
Product Development
QMS Refinement & Regulatory Submissions
Advance Exclusive
Webinar
Quality Assurance Management for Medical Devices (Level 2)
QA, medical device, medtech
Limited Availability
13 Courses
Risk Management
CAPA
Audit
IVDR
QMS
Quality Management
Advance Exclusive
Quality Assurance
A Complete Guide to 21 CFR Part 11
In this comprehensive guide, we’ll take you through each section of 21 CFR Part 11, explaining what the requirements actually mean and expounding the most important points for you to know as a medical device company.
Initial QMS Procedures
QMS Refinement & Regulatory Submissions
Advance Exclusive
eBook
A Step-By-Step Guide to Determine how your Medical Device will be Classified
In this guide, I will provide you with a step-by-step approach for determining how your medical device will be classified by U.S. FDA, the European Commission, and Health Canada. Getting a basic understanding of regulatory product classification will be invaluable to your efforts to bring new products to market.
Device Classification
Ideation & Prototyping
Initial QMS Procedures
Product Development
QMS Refinement & Regulatory Submissions
Advance Exclusive
eBook
Breakout Session: Best Quality Practices for SaMD, Including AI and ML
0 hr 43 min
SAMD
Advance Exclusive
Webinar
Economic Operators: Implementation Challenges and Opportunities
Learn about the changing responsibilities for Economic Operators in the medical device industry and how to turn compliance into opportunities for your business.
0 hr 53 min
Initial QMS Procedures
QMS Refinement & Regulatory Submissions
Product Launch
Advance Exclusive
Webinar
The Ultimate Guide to Document Control for Medical Device Companies
This in-depth guide will take a deep dive into the problems that tend to afflict document control activities, provide detailed explanations of the procedures that make your documentation more efficient, and offer proven effective methods for implementing and leveraging a robust document management system that will catapult the success of your organization and medical device.
Currently Unavailable
Document Management
Change Management
ISO 13485
QMS
Initial QMS Procedures
Post-Market Surveillance
Advance Exclusive
eBook
Using the Bucket Method for Medical Device Risk Management
Mike Drues joins the podcast again to talk some more about Risk Management
Currently Unavailable
Risk Management
Initial QMS Procedures
Product Development
QMS Refinement & Regulatory Submissions
Product Launch
Advance Exclusive
Podcast
Introduction to Design Control for Medical Devices
Learn how to be effective in medical device product development and design during this self paced, interactive online course.
$350
8 - 16 hours
Design Controls
Quality Management
Product Development
Certificate
Course
Premium
$101 - $500
Implementing and Maintaining Changes to SaMD Under MDR
This session will cover the outline of MDR requirements for SaMD, including qualification and classification, clinical evaluation and expanded post-market activities among others.
Currently Unavailable
0 hr 51 min
Product Development
QMS Refinement & Regulatory Submissions
Advance Exclusive
Webinar
The Definitive Guide to Change Management for Medical Devices
This guide will detail the change management best practices that medical device companies need to understand and follow when making changes to documents, products, processes, and more.
Currently Unavailable
Document Management
Change Management
Initial QMS Procedures
Product Launch
Post-Market Surveillance
Advance Exclusive
eBook
Foundations of Safe Medical Device Development and Manufacturing
The medical device development process, biocompatibility, Bill of Material (BOM), UDI, Usability Engineering, 3D printing in manufacturing.
$100
5 courses
manufacturing
biocompatibility
UDI
Usability Engineering
Learning Path
Product Development
Advance Exclusive
Course Package
0-$100
Quality Assurance Management for Medical Devices (Level 1)
QA, medical device, medtech
Limited Availability
13 Courses
Risk Management
Document Management
Change Management
Audit
ISO 14971
Quality Management
Advance Exclusive
Quality Assurance
Ultimate Guide to 21 CFR Part 820 - FDA's Quality System Regulation for Medical Devices
Join Medical Device Guru Taylor Brown for a discussion on the requirements of 21 CFR Part 820 and why it might not be as challenging as it first seems to meet those requirements..
Currently Unavailable
Risk Management
Document Management
CAPA
Design Controls
QMS
Initial QMS Procedures
Post-Market Surveillance
Advance Exclusive
eBook
The Power of 3D-Printed Medical Devices
This module will explore how 3D printing technology is shaking up the medical device industry and opening up new opportunities to improve patient outcomes.
0 hr 22 min
manufacturing
Product Development
Advance Exclusive
3D Printing
Standard (Free)
Course
How to Apply Risk Management Throughout the Product Lifecycle of your Medical Device
A session by Mike Baca, President at White Rook Consulting
Currently Unavailable
0 hr 48 min
Ideation & Prototyping
Initial QMS Procedures
Product Development
QMS Refinement & Regulatory Submissions
Product Launch
Post-Market Surveillance
Advance Exclusive
Webinar
Effective Post-market Surveillance in the EU under MDR
Check out this engaging discussion if you are looking to know more about how EUMDR is changing post-market surveillance.
0 hr 51 min
QMS Refinement & Regulatory Submissions
Product Launch
Post-Market Surveillance
Advance Exclusive
Webinar
Quality Assurance Management for Medical Devices (Level 3)
QA, medical device, medtech
Limited Availability
13 Courses
Risk Management
Document Management
Change Management
EU MDR
IVDR
ISO 13485
ISO 14971
SAMD
cybersecurity
Quality Management
Advance Exclusive
Quality Assurance
The Ultimate Guide to Training Management for Medical Device Companies
This ultimate guide provides an in-depth look at answers to those common questions and explains everything you need to know to comply with the applicable requirements as well as establish a training management system that promotes total competence of the members of your medical device organization.
Currently Unavailable
Training
ISO 13485
QMS
Initial QMS Procedures
Post-Market Surveillance
Advance Exclusive
eBook
Product Development and Engineering Checkpoint Delta
What an accomplishment! You spent the time, invested in your own knowledge, and now it's time to celebrate. Now hop in here and get your Guru Badge, so you can show off a little.
Currently Unavailable
Advance Exclusive
The Beginners Guide to Design Verification and Design Validation for Medical Devices
In this guide, we’ll go through the basics of design verification, design validation, best practices you should deploy, pitfalls you should avoid, and plans that will make it all come together.
Currently Unavailable
Design Controls
Product Development
QMS Refinement & Regulatory Submissions
Advance Exclusive
eBook
Product Development and Engineering Checkpoint Beta
You're graduating to the level of "Authority". You know your stuff and it's time you got a shiny new badge to prove it. Check-in here and you'll be ready to move on to level 3!
Currently Unavailable
Advance Exclusive
Product Development and Engineering for Medical Devices (Level 4)
You are so close! The fourth and final portion of this path will explore more advanced topics like usability, agile design and development, and application of design principles.
Limited Availability
10 Courses
Risk Management
Design Controls
Change Management
EU MDR
IVDR
ISO 13485
Device Classification
ISO 14971
FDA
SAMD
Usability Engineering
Product Development
Advance Exclusive
How to Integrate Risk Management Throughout the Lifecycle of a Medical Device
Join Greenlight Guru Founder, Jon Speer, as he discusses the next decade of risk in the medical device industry.
Limited Availability
Risk Management
ISO 14971
Ideation & Prototyping
Initial QMS Procedures
Product Development
QMS Refinement & Regulatory Submissions
Product Launch
Post-Market Surveillance
Advance Exclusive
Webinar
Quality Assurance Management for Medical Devices (Level 4)
QA, medical device, medtech
Limited Availability
13 Courses
Risk Management
Change Management
Training
Audit
EU MDR
ISO 14971
biocompatibility
cybersecurity
Complaints
Quality Management
Advance Exclusive
Quality Assurance
Product Development and Engineering for Medical Devices (Level 1)
Ready to take a learning journey with us? We've compiled all of our favorite content related to product development and engineering for medical devices, and we think you're going to love it. Finish this first leg of the journey and earn your Specialist Badge.
Limited Availability
10 Courses
Risk Management
Design Controls
ISO 14971
Product Development
Advance Exclusive
How to Meet Cybersecurity Requirements of EU MDR & IVDR
EU MDR and IVDR are changing and cybersecurity requirements are no exception. Get the details in this important discussion with Justin from TUV SUD.
Currently Unavailable
0 hr 54 min
Initial QMS Procedures
Product Development
QMS Refinement & Regulatory Submissions
Advance Exclusive
Webinar
Product Development and Engineering for Medical Devices (Level 3)
Now that you're starting to get a feel for things let's dive deeper. This combination of guides, courses, and webinars will have you feeling ready for any product development challenge as you make your way to your Expert Badge.
Limited Availability
11 Courses
Risk Management
Design Controls
EU MDR
IVDR
ISO 13485
510(k)
ISO 14971
FDA
SAMD
manufacturing
cybersecurity
Product Development
Advance Exclusive
Product Development and Engineering for Medical Devices (Level 2)
On to level 2! Take a closer look at core topics like Design Controls and Risk Management as you make your way toward your Level 2 badge.
Limited Availability
11 Courses
Risk Management
Design Controls
Change Management
EU MDR
ISO 13485
Device Classification
510(k)
ISO 14971
FDA
Product Development
Advance Exclusive
Regulatory Affairs for Medical Devices (Level 1)
Essential learning for RA professionals in an easy to follow path you can complete at your own pace.
Limited Availability
13 Courses
Risk Management
Document Management
Design Controls
EU MDR
IVDR
QMS
510(k)
ISO 14971
FDA
Regulatory Management
Product Development
Advance Exclusive
Introduction to Software for Medical Devices and IEC 62304
Learn how to be effective in medical device software development during this self paced, interactive online course.
$500
10 - 16 hours
SAMD
Initial QMS Procedures
Product Development
QMS Refinement & Regulatory Submissions
Product Launch
Certificate
Course
Premium
$101 - $500
Risk Management Strategies for AI in Medical Devices
Speaker: HTEC Group
0 hr 50 min
Standard (Free)
Webinar
How to Implement Risk Management into Regulatory Submissions Using Tips, Tricks, and Standards to Satisfy FDA Concerns
A session by Mary McNamara-Cullinane. Senior Vice President of Regulatory Affairs, Alira Health.
0 hr 47 min
Product Development
QMS Refinement & Regulatory Submissions
Standard (Free)
Webinar
Winning Hearts, Changing Minds: How to Build a Risk-Aware Culture in Medtech
Speaker: Christie Johnson | Partner at Prodct
0 hr 50 min
Risk Management
Standard (Free)
Webinar
Strategies to Limit Project Timeline and Cost in Medical Devices
A session by Milton Yarberry, Director of Medical Programs at ICS
0 hr 50 min
Ideation & Prototyping
Initial QMS Procedures
Product Development
Product Launch
Webinar
Design Control 101
Join our partners from Kapstone medical as they discuss the basics and how to get started with design control for medical devices.
0 hr 48 min
Design Controls
Ideation & Prototyping
Product Development
Webinar
Connecting Post-Market Studies with Your Commercial Strategy
Speaker: Wojciech Bobela, PhD RAC | Clinical Affairs Manager at Ziemer Opthalmics Snorri Helgason | Director of Market Access at Nox Medical
0 hr 48 min
Funding
Post-Market Surveillance
Regulatory Strategy
Standard (Free)
Webinar
What Role Should Quality Play in Bringing a Device to Market?
A session by Jon Speer, Founder at Greenlight Guru
0 hr 50 min
Ideation & Prototyping
Product Launch
Standard (Free)
Webinar
Basic Molecular Biology Module 2: Laboratory Practice
This basic-level eLearning course provides information on general laboratory practices. Topics covered include biosafety practices, laboratory area flow, and practices to minimize contamination.
0 hr 50 min
Clinical
Clinical Trials
Lab Best Practices
Course
Lessons Learned: MedTech Executives on the Fundraising Process
Join this experience-packed panel as they discuss medical device fundraising and how to navigate this important part of your medtech journey.
0 hr 48 min
Funding
Ideation & Prototyping
Post-Market Surveillance
Standard (Free)
Webinar
How Electronic Data Capture Is Transforming the MedTech Industry
A Talk by Jon Bergsteinsson, Autumn Dawn Lang PhD, RAC and Rianne Tooten: Greenlight Guru, VeriSkin Inc. and Rianne Tooten
Standard (Free)
Webinar
So You Think You Want to go to Europe? Considerations for Early Adopters of MDR
A session by Michelle Lott, Regulatory Strategist, Principal, and Founder at Lean RAQA
0 hr 46 min
EU MDR
Initial QMS Procedures
Standard (Free)
Webinar
Risks that No One Wants to Talk About: Theoretical Risk Management vs. Life in the Real World
A session by Mike Drues Ph.D., President at Vascular Sciences
0 hr 55 min
Initial QMS Procedures
Product Development
QMS Refinement & Regulatory Submissions
Product Launch
Standard (Free)
Webinar
QMS from a Regulatory Perspective
Carmen Brown: Regulatory Affairs Manager, Proxima Clinical Research
0 hr 48 min
QMS
Regulatory Management
Initial QMS Procedures
QMS Refinement & Regulatory Submissions
Standard (Free)
Course
The Risk Management + Design Controls Connection: What Device Makers Need to Know
Greenlight Guru found Jon Speer discusses why design controls and risk management should flow and blend together, and it’s important to establish this flow early in product development.
Risk Management
Design Controls
Product Development
Standard (Free)
eBook
What to do when FMEA is Not Sufficient Anymore
A session by Peter Sebelius, Founder at Medical Device HQ
0 hr 48 min
Product Development
Standard (Free)
Webinar
EU MDR: Are you on Pace?
A talk by Adnan Ashfaq, Michael Galliker, Laurie Rowe and Craig Story: Simplimedica, Regulatory Globe, RED Medtech and UDICAAS
0 hr 47 min
EU MDR
IVDR
Regulatory Management
QMS Refinement & Regulatory Submissions
Standard (Free)
Webinar
How to Prepare for Common MDR Audit Pitfalls
A session by Bassil Akra, CEO and Co-Owner, QUNIQUE GmbH
0 hr 53 min
Initial QMS Procedures
QMS Refinement & Regulatory Submissions
Product Launch
Post-Market Surveillance
Standard (Free)
Webinar
Key Trends Shaping the Future of Medtech Innovation & Investment
A session by Paul Grand and Glenn Snyder from Medtech Innovator and Deloitte
0 hr 53 min
Funding
Ideation & Prototyping
Post-Market Surveillance
Standard (Free)
Webinar
QMSR Harmonization - The Good the Bad and the Ugly
A talk by Seyed Khorashahi Executive VP of Medical Devices and CTO, Regulatory Compliance Associates (RCA)
0 hr 50 min
Audit
ISO 13485
510(k)
FDA
Regulatory Management
QMS Refinement & Regulatory Submissions
Standard (Free)
Webinar
Key Milestones: How to Know When You're Ready for Your Next Round of Funding
A session by David Cassak and Casey McGlynn of Medtech Strategist and WSGR
0 hr 43 min
Funding
Ideation & Prototyping
Post-Market Surveillance
Standard (Free)
Webinar
UDI and Device Registration, Another Launch Checkbox
A session by Gary Saner, Sr Mgr of Information Solutions at Reed Tech
0 hr 49 min
UDI
QMS Refinement & Regulatory Submissions
Post-Market Surveillance
Webinar
AMA session on Regulatory Strategy with Michelle Lott
This weeks topic is on Regulatory Strategy with Michelle Lott.
QMS
Regulatory Management
QMS Refinement & Regulatory Submissions
Standard (Free)
Podcast
Fundamentals of Chemical Fume Hood Safety
This basic-level eLearning course provides an essential understanding of the major components of a chemical fume hood and proper practices for its safe and effective operation.
0 hr 50 min
Lab Best Practices
Course
AMA session on Risk Management with Mark Swanson from QRXPartners
This weeks topic is Risk Management with Mark Swanson from QRXPartners
Risk Management
QMS
Product Development
QMS Refinement & Regulatory Submissions
Podcast
The Road to 2024: Regulatory Risks Related to Changed Post-Market Surveillance Requirements and Notified Body Certification
The presentation examines the post-Date of Application period, including - The MDR has more detailed formal PMS requirements.
0 hr 51 min
Regulatory Management
QMS Refinement & Regulatory Submissions
Standard (Free)
Webinar
AMA session on Contract Manufacturing with Mark Rutkiewicz from Innovize
This weeks topic is over the Contract Manufacturing for Medical Devices. We hope you enjoy!
QMS
manufacturing
Supplier Management
Quality Management
Product Development
Standard (Free)
Podcast
Supply Chain Management under the MDR, Brexit and Swixit
As a result of the MDR, Brexit and Swixit, manufacturers need to be fully aware of how these changes may impact their current and future supply chain Europe.
0 hr 49 min
Initial QMS Procedures
Product Launch
Post-Market Surveillance
Standard (Free)
Webinar
Regulatory & Product Development: Relationship Counseling Course
A talk by Carolyn Algar Guthrie MS RAC, Carrie Hetrick, Dylan Horvath and Justin Matchett: Kapstone, Sterling Medical Devices, Cortex Deisgn and HS Design
0 hr 49 min
QMS
Regulatory Management
Product Development
QMS Refinement & Regulatory Submissions
Webinar
How to Maintain a QMS Compliant to MDR & IVDR
Your QMS should be your source of truth, but what happens when the requirements for a QMS change? Get equipped to meet EUMDR and IVDR standards by checking out this talk from Kyle Rose.
0 hr 52 min
Initial QMS Procedures
QMS Refinement & Regulatory Submissions
Post-Market Surveillance
Webinar
The Importance of Product Classification to Regulatory Strategy
A session by Daryl Wisdahl, Senior Consultant, Quality and Regulatory Affairs at Emergo by UL
0 hr 51 min
Device Classification
Regulatory Management
Ideation & Prototyping
QMS Refinement & Regulatory Submissions
Standard (Free)
Webinar
Reducing Friction Between Companies and Regulatory Bodies
A talk by Simon Wieser: Project Leader and Auditor for MDR and MDSAP, TÜV SÜD
0 hr 49 min
EU MDR
IVDR
QMS
Regulatory Management
QMS Refinement & Regulatory Submissions
Standard (Free)
Webinar
Prepare Now for the EUDAMED UDI/Registration Module
UDI data requirement experts Gary Saner and John Lorenc of Reed Tech will discuss best practices for UDI preparations for the upcoming EUDAMED UDI/Registration Module.
0 hr 59 min
Initial QMS Procedures
QMS Refinement & Regulatory Submissions
Product Launch
Webinar
The Compliance Concern: Challenges and Roadblocks for Ensuring Compliance in 2023
A Talk by Carlos Almeida, Amanda Feddersen, Weronika Michaluk and David Shanes: SPK and Associates, Monitored Therapeutics Inc., HTD and Fullpower Technologies Inc.
Standard (Free)
Webinar
Essentials for Clinical Evaluation of Medical Devices
The Globiox team will discuss how the latest updates to EU MDR & IVDR may impact your approach to post-market clinical follow-ups, how to optimally demonstrate equivalency in your report, and how to establish a continuous follow-up process for post-market.
0 hr 53 min
Initial QMS Procedures
QMS Refinement & Regulatory Submissions
Clinical
Standard (Free)
Webinar
AMA Session on Clinical Investigations with Smart Trial
This weeks topic is on Clinical Trials with Jón Ingi Bergsteinsson & Páll Jóhannesson from Smart Trial.
Clinical
SMART-TRIAL
Standard (Free)
Podcast
Europe's First Device Regulations: A Look Into Manufacturers' Response to the Delay, Transition, & Implementation Process
Jon Speer, Founder of Greenlight Guru, will dive into key data and findings from Greenlight Guru's upcoming EU MDR Report, which surveyed hundreds of medical device professionals from all over the world.
0 hr 57 min
QMS Refinement & Regulatory Submissions
Product Launch
Post-Market Surveillance
Standard (Free)
Webinar
Common Misconceptions on Medical Device Risk & Design Controls
A talk by Rob MacCuspie: Quality and Regulatory Manager, Proxima Clinical Research
0 hr 54 min
Risk Management
Design Controls
QMS
Initial QMS Procedures
QMS Refinement & Regulatory Submissions
Webinar
Computer Software Assurance (CSA): Understanding the FDA's New Draft Guidance
Francisco Vincenty: Case for Quality Program Manager, FDA
0 hr 50 min
Design Controls
QMS
510(k)
FDA
SAMD
Quality Management
Regulatory Management
Initial QMS Procedures
Product Development
QMS Refinement & Regulatory Submissions
USA
Computer Software Assurance
Standard (Free)
Webinar
Insights on the MedTech Regulatory and Clinical Environment in Israel
A talk by Adi Ickowicz Engineer, IQVIA MedTech
0 hr 45 min
QMS
Regulatory Management
QMS Refinement & Regulatory Submissions
Clinical
Webinar
Why You Need to Use IEC 62304 for Software Development
A session by Cathy Wilburn, Director of Quality Assurance and Compliance, The RND Group
0 hr 48 min
SAMD
Ideation & Prototyping
Product Development
Standard (Free)
Webinar
How to Map Agile Processes for Medical Device Design Control Using SCRUMBAN Framework
Speaker: Tanima Ghosh | Principal Medical Device Consultant at Enerxen Consulting Inc.
0 hr 51 min
Design Controls
Ideation & Prototyping
Initial QMS Procedures
Product Development
Standard (Free)
Webinar
Product Showcase: Greenlight Guru Academy Advance
0 hr 9 min
Training
Greenlight Guru Platform
Standard (Free)
Webinar
Leveraging Modern Software Technologies: MedTech’s Best Kept Secret
A Talk by Damini Agarwal, Som Pathak, Michael Roberts and Maxime Rochon: Infinite Biomedical Technologies, LLC., NSV, SPK and Associates and Puzzle Medical Devices
Webinar
MDSAP Certification: Success and Failures
A talk by Danny Kroo President, Docusys Corporation
0 hr 48 min
Audit
MDSAP
Regulatory Management
QMS Refinement & Regulatory Submissions
Standard (Free)
Webinar
Behind the Stats: Expectations vs. Reality of Bringing a Device to Market
A talk by Etienne Nichols and Radhika Pandya of Greenlight Guru
Standard (Free)
Webinar
Managing Changes to Medical Device QMS
This white paper provides an overview into some of the major changes happening right now, and provides some recommendations to consider when managing these changes. It covers changes to ISO 13485:2016, the EU Medical Device Regulation and In Vitro Diagnostic Device Regulation.
EU MDR
IVDR
ISO 13485
Initial QMS Procedures
Post-Market Surveillance
eBook
State of Swexit/Brexit
A talk by Matthias Bissig and Patricia Vest from Inmedis and MDSSPRO
0 hr 49 min
EU MDR
IVDR
ISO 13485
Regulatory Management
QMS Refinement & Regulatory Submissions
Webinar
The Intersection of Medical Device Usability and Risk Management
Mike Drues joins the podcast again to talk some more about Risk Management
Risk Management
ISO 14971
Product Development
QMS Refinement & Regulatory Submissions
Standard (Free)
Podcast
How to Successfully Plan a Medical Device Product Development Project
A session by Peter Sebelius, Founder at Medical Device HQ
0 hr 46 min
Product Development
Webinar
How to Embrace Risk for Safer Devices
Check out one of our favorite podcast episodes from the Global Medical Device Podcast with Tim Moulton, Founder and President at Motim Industries
Risk Management
Ideation & Prototyping
Product Development
QMS Refinement & Regulatory Submissions
Standard (Free)
Podcast
Making Headway Despite the Turbulence: Regulatory Requirements, Quality, and your QMS
A talk by Joanne Lebrun: Vice President of Quality, MDC Associates, Inc.
0 hr 56 min
EU MDR
ISO 13485
QMS
FDA
Quality Management
Regulatory Management
QMS Refinement & Regulatory Submissions
Standard (Free)
Webinar
Risk Management for Executives: Why Does it Matter to Me?
A session by Michael Cremeans, Life Sciences Industry Practice Leader at Hylant
0 hr 44 min
Webinar
QMSR Harmonization: The Future of FDA's Quality Management System Regulation
A talk by Dr. Deepa Pandia: NAM Auditing Department Manager, TÜV SÜD
0 hr 53 min
QMS
FDA
Quality Management
Initial QMS Procedures
QMS Refinement & Regulatory Submissions
Standard (Free)
Webinar
Balancing Innovation & Regulation: Navigating Design Development While Keeping Quality and Regulatory in Mind
1 hr 0 min
Design Controls
Quality Management
Regulatory Management
Ideation & Prototyping
Initial QMS Procedures
Product Development
QMS Refinement & Regulatory Submissions
Standard (Free)
Webinar
Designing an International Regulatory Strategy: Why do so many get it wrong?
A talk by Michael Drues PhD and Etienne Nichols Vascular Sciences and Greenlight Guru
0 hr 50 min
CAPA
Change Management
Audit
EU MDR
IVDR
ISO 13485
Device Classification
510(k)
ISO 14971
FDA
MDSAP
Regulatory Management
QMS Refinement & Regulatory Submissions
Standard (Free)
Webinar
Behind the Stats: 2022 Medical Device Product Development & Quality Management Benchmark Survey
Learn more about our annual survey and the results we've seen from this years respondents. Join Community Manager and Medical Device Guru Etienne Nichols as he unravels the data and shares his perspective on these findings.
0 hr 54 min
Quality Management
Product Development
QMS Refinement & Regulatory Submissions
Product Launch
Post-Market Surveillance
Webinar
Basic Molecular Biology Module 3: Nucleic Acid Extraction
This basic-level eLearning course, Module 3, provides information on nucleic acid extraction. Topics covered include extraction method selection, basic extraction steps, and nucleic acid analysis.
0 hr 50 min
Lab Best Practices
Course
MDR Date of Application Roundup: The New Landscape for Medical Device Manufacturers
A session by Evangeline Loh, VP of Regulatory Affairs at Emergo by UL
0 hr 47 min
Product Development
QMS Refinement & Regulatory Submissions
Post-Market Surveillance
Standard (Free)
Webinar
Marketing Your Medical Device
Speaker: Mark DuVal | CEO & President of Duval Associates
0 hr 50 min
Post-Market Surveillance
Webinar
The New MDR: Is it Really New and Do We Really Need It?
A session by Mike Drues Ph.D., President at Vascular Sciences
1 hr 5 min
Initial QMS Procedures
QMS Refinement & Regulatory Submissions
Product Launch
Webinar
Documenting Risk Management to Meet Requirements of ISO 14971:2019
A session by Edwin Bills, Consultant
0 hr 50 min
ISO 14971
Regulatory Management
Initial QMS Procedures
Product Development
QMS Refinement & Regulatory Submissions
Product Launch
Post-Market Surveillance
Standard (Free)
Webinar
ISO 13485: What's Next?
Chandler Thames: Director of Quality, Rook Quality Systems
0 hr 47 min
ISO 13485
QMS
Quality Management
Regulatory Management
Initial QMS Procedures
QMS Refinement & Regulatory Submissions
Webinar
Adhering to and Preparing for Changing Clinical Requirements Around the Globe
A talk by Jon Ingi Bergsteinsson M.Sc., Matt Wagener and Alethea Wieland: SMART-TRIAL, Proxima Clinical Research, Inc and Clinical Research Strategies, LLC
1 hr 2 min
EU MDR
ISO 13485
QMS
FDA
Regulatory Management
QMS Refinement & Regulatory Submissions
Clinical
Webinar
Risk Management According to EU MDR or ISO 14971?
A session by Peter Sebelius, Founder at Medical Device HQ
0 hr 53 min
ISO 14971
Regulatory Management
Ideation & Prototyping
Product Development
QMS Refinement & Regulatory Submissions
Product Launch
Standard (Free)
The ROI of Shifting Mindset From Compliance to Quality
A Talk by Edwin Chung, Aaron Gifford, Daniel Powell and Jeff Schwegman: SPK and Associates, Nectar, Spark Biomedical and Recovery Force
Standard (Free)
Latin American Regulations - What you Don't Know
A talk by Marcelo Brisolla and Josué Garza: Brisa Advisors and Insumos para la Salud, S.A. de C.V.
0 hr 51 min
QMS
Regulatory Management
QMS Refinement & Regulatory Submissions
Standard (Free)
Webinar
The Most Common Mistakes Health Tech Founders Make When Pitching
A session by Adam Dakin, Managing Director at DreamIt Ventures
0 hr 50 min
Ideation & Prototyping
Standard (Free)
Webinar
UDI - US vs EU: What You Need to Know
A talk by John Lorenc and Gary Saner: Reed Tech and LexisNexis Reed Tech
0 hr 45 min
EU MDR
FDA
UDI
Regulatory Management
QMS Refinement & Regulatory Submissions
Standard (Free)
Webinar
Understanding UDI
Our partners Reed Tech shed light on the global requirements surrounding UDI and share several helpful resources to keep you compliant in this area.
UDI
Standard (Free)
AMA: Join the discussion with the MedTech Excellence Community
The MedTech Excellence Community will be hosting AMA (ask me anything) sessions and has invited Academy learners to participate! Ask industry experts, meet your peers, and improve the quality of life by adding your voice to the discussion.
Standard (Free)
Podcast
Artificial vs. Applied Intelligence in Risk: Fueiling a Probabilistic Risk Assessment
Speaker: Tyler Foxworthy
0 hr 50 min
Standard (Free)
Webinar
eMDR Program and Process
Alireza Hemmati: Senior Product Assessment, TÜV SÜD
0 hr 47 min
EU MDR
QMS
Quality Management
Regulatory Management
Initial QMS Procedures
QMS Refinement & Regulatory Submissions
EU
Standard (Free)
Webinar
The Path to Commercialization is No Easy Feat: Critical Milestones and Challenges
Bringing a device to market? This panel discussion will give you a lot to think about and probably help you avoid many pitfalls along the way.
1 hr 2 min
Funding
Quality Management
Regulatory Management
Initial QMS Procedures
Product Development
QMS Refinement & Regulatory Submissions
Product Launch
Standard (Free)
Webinar
MDR with Brexit: How the Combination is Impacting the European Medical Device Industry
In this presentation we will be discussing the status of the medical device industry regarding MDR and Brexit, and what are others doing to get ready.
0 hr 53 min
Webinar
FDA Today - EUA & SaMD
A talk by Allison Komiyama PhD and Michael Nilo: RQM+ President and Principal Consultant
0 hr 51 min
FDA
SAMD
cybersecurity
QMS Refinement & Regulatory Submissions
Webinar
Fundamentals of Centrifuge Safety
This basic-level eLearning course provides information on the safe use of centrifuges. Topics covered include major parts of a centrifuge, types of centrifuges, potential hazards, how to work safely with a centrifuge, and what to do if there is an emergency.
0 hr 50 min
Lab Best Practices
Standard (Free)
Course
Navigating Uncertainty_ Quality, Regulatory & Clinical Strategies to Accelerate Medical Device Approval
Speaker: Ruba Sarris Sawaya | CEO at MediStrat360 LLC
0 hr 50 min
Quality Management
Regulatory Management
Clinical
Webinar
Introducing Health Economics in Your Pre-Market Clinical Studies
Speaker: Pall Johannesson | Managing Director at Greenlight Guru
0 hr 50 min
Clinical
Clinical Trials
Pre-Market
Standard (Free)
Webinar
SEEDing Biomedical Innovation: Support for Small Businesses at NIH
This session will highlight NIH’s strategic focus on early product development, resources, and opportunities available to small business innovators.
0 hr 46 min
Funding
Ideation & Prototyping
Webinar
AI Security for SaMD: Fortifying AI Systems against Attacks in Medical Technologies
Speakers: AI Shield
0 hr 50 min
Standard (Free)
Webinar
AMA session on SaMD Cybersecurity with Chris Gates from Velentium
This weeks topic is over the Cybersecurity for SaMD and is with Chris Gates, author of Medical Device Cybersecurity, and Director of Product Security at Velentium. Chris is considered throughout the industry to be a thought leader in all aspects of medical device cybersecurity.
QMS
cybersecurity
Quality Management
Initial QMS Procedures
Product Development
Standard (Free)
Podcast
Who Owns Risk Management and How Does it Impact the Business?
A session by Jon Speer, Founder at Greenlight Guru
1 hr 1 min
Ideation & Prototyping
Product Development
Function
Webinar
Preparing a Device Master Record (DMR)
Speaker: Stephen Coulter, Ph.D. | General Manager at RCA
0 hr 48 min
Design Controls
Product Development
Device Master Record (DMR)
Webinar
Covering the Bases: Preparation for EU MDR Risk Management
Speaker: Rook QS
0 hr 50 min
Standard (Free)
Webinar
Moving up to the State of the Art in Risk Management
Ed Bills: ASQ Fellow, RAC, Consultant: Edwin Bills Consulting
0 hr 52 min
Risk Management
QMS
ISO 14971
Quality Management
Regulatory Management
Initial QMS Procedures
QMS Refinement & Regulatory Submissions
Standard (Free)
Webinar
Basic Molecular Biology Module 4: PCR and Real-Time PCR
This basic-level eLearning course provides information on the principle of PCR and real-time PCR. Topics covered include PCR steps, PCR product analysis, and real-time PCR characteristics.
0 hr 50 min
Lab Best Practices
Standard (Free)
Course
Basic Molecular Biology Module 1: Basic Science
The basic-level eLearning course provides information on the fundamental characteristics of DNA and RNA, nucleotide base-pairing rules, and the basic techniques and workflow applied in molecular diagnostics.
0 hr 50 min
Clinical
Clinical Trials
Lab Best Practices
Course
Do it by Design: How Usability Brings Value to Risk Controls
Speaker: CLEIO
0 hr 50 min
Product Development
Webinar
MDR by the Numbers: Leveraging New Data for Implementation Planning
After the wake of the initial and then the first extension of the MDR deadline, the EU regulatory landscape is still reeling from the new requirements. Now facing the possibility of another extension, the medical device industry is further confused not only about requirements themselves but also if and when they must comply.
1 hr 27 min
EU MDR
Webinar
Navigating APAC Regulations for Medical Device Companies
A talk by Pierre Lonchampt, Andrew See and Andrew Wu: Diapason Consulting, Medipro Consultancy and Services and Rook Quality Systems
0 hr 52 min
QMS
Regulatory Management
QMS Refinement & Regulatory Submissions
APAC
Standard (Free)
Webinar
Navigating AI Risks for Regulatory Approval in Medical Devices
Speaker: Isabella Schmitt | Proxima CRO
0 hr 50 min
Regulatory Management
True Summit Series
Standard (Free)
Webinar
FDA vs EU Requirements
Speaker: Carolyn Algar Guthrie, MS RAC | Regulatory & Quality at Kapstone Medical
0 hr 49 min
EU MDR
FDA
Regulatory Management
QMS Refinement and Regulatory Submission
Standard (Free)
Webinar
How Risk Management Can Help Drive Innovation
A session by Michael Quinn, Vice President of Design and Engineering at HS Design
0 hr 46 min
Ideation & Prototyping
Product Development
Webinar
Panel: Funding and Go to Market Challenges for FemTech
Join us for this powerful conversation about the particular challenges facing FemTech founders and companies in the current landscape.
1 hr 0 min
Funding
Ideation & Prototyping
Webinar
AMA on Quality Communication
A conversation with Lesley Worthington, J.D. about best practices for communicating as a quality professional.
Quality Management
Podcast
Risk Management & Agile Development of AI Software as Medical Device
Speakers: Weronika Michaluk | HTD Health
0 hr 50 min
Standard (Free)
Webinar
Talent Management Strategies: “Design Quality” for Commercialization
Speaker: Darwin Shurig | CEO & Founder at Shurig Solutions
0 hr 53 min
Design Controls
Quality Management
Product Development
Webinar
Unannounced Audits by Your Notified Body
Speaker: Umesh Soni | Lead Auditor at TÜV SÜD
0 hr 48 min
Audit
EU MDR
Post-Market Surveillance
Webinar
How to Implement a Quality Culture
There’s a difference between meeting quality regulatory standards and fostering a quality culture in your company, and this micro-learning will help us think about how to make sure we are doing the latter.
0 hr 15 min
Quality Management
Standard (Free)
Course
US FDA 101
A session by Carolyn Guthrie, Director QA/RA at Kapstone Medical
0 hr 49 min
510(k)
FDA
Initial QMS Procedures
Product Development
QMS Refinement & Regulatory Submissions
Product Launch
Webinar
The Global Guide to Human Factors and Usability Engineering Regulations
A talk by Bryant Foster Sr. VP of Human Factors & UX, Research Collective
0 hr 53 min
Usability Engineering
Standard (Free)
Webinar
How to Integrate Risk Management Throughout the Lifecycle of a Medical Device in the Coming Decade
Speaker: Time Slot
0 hr 50 min
True Summit Series
Webinar
QMS Best Practices for SaMD and Devices Featuring Software
This microlearning course is designed to equip you with essential knowledge and best practices for successfully implementing a QMS tailored to the unique needs of SaMD and other medical devices with software.
0 hr 15 min
QMS
SAMD
Initial QMS Procedures
QMS Refinement & Regulatory Submissions
Standard (Free)
Scaling Manufacturing_ 12 Key Questions
Speaker: Dan Purvis | CEO and Co-Founder at Velentium
0 hr 50 min
manufacturing
Webinar
Preparing for the Upcoming FDA Quality Management System Regulation
Speakers: Ed Bills & Christie Jonhson
0 hr 50 min
Webinar
Time to include Root Cause Analysis in Risk Management and Why Team NB is Wrong
Speakers: Peter Selebius
0 hr 50 min
Webinar
Fundamentals of Working Safely in a Biological Safety Cabinet
This basic-level eLearning course provides information on the safe use of Class II biological safety cabinets.
Limited Availability
0 hr 50 min
Lab Best Practices
Course
Market Access Strategy
A session by Leslie Wise, CEO and Managing Director at evidencematters
0 hr 40 min
Ideation & Prototyping
Webinar
ISO 14971 Risk Management for Medical Devices
Use this guide to align with the latest version of ISO 14971 and to learn additional tips and insights for medical device risk management.
Risk Management
QMS
ISO 14971
Ideation & Prototyping
Initial QMS Procedures
Product Development
QMS Refinement & Regulatory Submissions
Product Launch
Post-Market Surveillance
eBook
Introduction to Clinical Laboratory Improvement Amendments of 1988 (CLIA)
This basic-level eLearning course provides information on selected CLIA regulations. Topics covered include CLIA Regulatory Program Overview, CLIA Laboratory Testing and Quality Standards, and CLIA Program Oversight and Administration.
Limited Availability
1 hr 30 min
Lab Best Practices
CLIA
Course
Fundamentals of Personal Protective Equipment (PPE) in Clinical Laboratories
This course is designed to assist clinical and public health laboratory professionals with applying risk management strategies to identify hazards, assess risks, and select appropriate personal protective equipment (PPE) options.
Limited Availability
0 hr 50 min
Lab Best Practices
CLIA
Course
Introduction to Laboratory Informatics: Life of a Result
This basic-level eLearning course is the second of a two-part introductory module on laboratory informatics. The course provides information on the role and processes of laboratory informatics through exploration of the “life of a result” as data and results move through the laboratory and outside the laboratory.
Limited Availability
2 hr 0 min
Lab Best Practices
Course
Introduction to Laboratory Informatics: Life of a Specimen
This basic-level eLearning course is the first of a two-part introductory module on laboratory informatics. The course provides information on the role and processes of laboratory informatics through exploration of the “life of a specimen” as a specimen moves through the laboratory.
Limited Availability
2 hr 0 min
Lab Best Practices
Course
Packing and Shipping Dangerous Goods: What the Laboratory Staff Must Know
The goal of this course is to provide training on packing and shipping Division 6.2 infectious substances and dry ice. This course provides a certificate of completion, but does not provide certification for transport of dangerous goods. Individuals can only be certified by their employer.
Limited Availability
2 hr 0 min
Lab Best Practices
Course
Ready? Set? Test! Patient Testing is Important. Get the Right Results
The training will help to assure that testing personnel have the basic training necessary to safely and accurately perform patient testing waived under the Clinical Laboratory Improvement Amendments of 1988.
Limited Availability
2 hr 0 min
Lab Best Practices
CLIA
Course
Introduction to Laboratory Risk Management (LRM)
This basic level eLearning course provides details on applying risk management principles and briefly describes related practices to emphasize the importance of risk management in laboratory settings.
Limited Availability
1 hr 0 min
Risk Management
Lab Best Practices
Course
Laboratory Continuity of Operations (COOP) Planning Course
This basic-level eLearning course will provide the purpose and components of a laboratory COOP plan.
Limited Availability
3 hr 0 min
Lab Best Practices
Course
Introduction to the LIMS & Other Information Systems
This basic-level eLearning course provides an overview of the Laboratory Information Management System (LIMS) – also known as a Laboratory Information System – and other information systems that play a key role in laboratory informatics.
Limited Availability
1 hr 30 min
Lab Best Practices
Course
CLIA and Provider-Performed Microscopy (PPM) Procedures: An Introduction
This basic-level eLearning course provides information on selected topics, including: background of PPM procedures, overview of criteria, examinations, and regulations, how to apply for a CLIA Certificate for PPM Procedures, requirements for PPM personnel, and additional CLIA requirements and quality practices.
0 hr 50 min
Lab Best Practices
CLIA
Course
A Resource Pack for the MedTech Entrepreneur
Never leave home without it! These resources are always great to have on hand as you plan and execute you next great MedTech idea.
Template
Ideation & Prototyping
Initial QMS Procedures
Advance Exclusive
eBook
Learn how to advance your career with GG Academy!
Learn how to advance your MedTech team with GG Academy!
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Introduction to the Medical Device Regulation (EU) 2017/745
Learn about the European regulation for medical devices, MDR, and how to effectively implement its requirements during this self paced, interactive online course.
$450
15 - 20 hours
EU MDR
Quality Management
Regulatory Management
Initial QMS Procedures
QMS Refinement & Regulatory Submissions
Product Launch
Post-Market Surveillance
Certificate
Course
Premium
$101 - $500
Introduction to Probabilistic Risk Assessment for Medical Devices
Whether you are a medical device developer, regulatory professional, or simply curious about risk assessment, this course will provide you with a solid foundation in key concepts and techniques.
Risk Management
Course
How to Vet Medical Device Distributors in Multiple Markets
What does that vetting process look like? What are the questions you should be asking and the answers you should be looking for?
Standard (Free)
Introduction to Usability Engineering and IEC 62366-1
Learn how to establish a pragmatic usability engineering process that enables regulatory clearance and great product design during this self-paced, interactive online course.
$450
8 - 16 hours
Usability Engineering
Product Development
Certificate
Course
Premium
$101 - $500
Risk Management for Medical Devices and ISO 14971
In this course, you will gain an understanding of Risk Management in the context of the medical device industry. You will also learn about ISO 14971, the international standard that informs these best practices and is required by regulatory bodies around the world.
$400
4 - 8 hours
Risk Management
QMS
ISO 14971
Quality Management
Regulatory Management
Initial QMS Procedures
Product Development
QMS Refinement & Regulatory Submissions
$101 - $500
How to Use Clinical Data in Medical Device Submissions in the EU and USA
Greenlight Guru recently hosted a webinar with our friends at Avania on this topic. Let's look at the key takeaways on how clinical data can best be used for medical device submissions in the EU and US.
0 hr 22 min
EU MDR
FDA
Clinical
Standard (Free)
Course
🚨 CAPA, Nonconformance, and Complaints limited time offering 🚨
Get a sneak peak into how we train our very own Gurus here at Greenlight Guru with this course that covers CAPA, Nonconformance, and Complaints and shares some best practices for all three.
1 hr 0 min
Internal
Course
[separator] In-Depth MedTech Focus Areas
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[separator] New to Greenlight Guru?
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[separator] Foundational MedTech Principles
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Creating a Study (Super users)
SMART-TRIAL
Course
Entrepreneur's Guide Welcome Course
Limited Availability
Quality Assurance Manager Checkpoint Delta
What an accomplishment! You spent the time, invested in your own knowledge, and now it's time to celebrate. Now hop in here and get your Guru Badge, so you can show off a little.
Limited Availability
Advance Exclusive
The Power of 3D-Printed Medical Devices
This module will explore how 3D printing technology is shaking up the medical device industry and opening up new opportunities to improve patient outcomes.
0 hr 22 min
manufacturing
Product Development
Advance Exclusive
3D Printing
Standard (Free)
Course
An Overview of Human Factors Engineering for MedTech
Usability engineering is so important to medical device safety and efficacy, and we want to share more about this topic with you. This short course will get you started on the path to understanding this crucial skill.
30 min
Usability Engineering
Product Development
Course
The Basics of Bill of Materials (BOMs) for MedTech
Trust us, these BOMs are perfectly safe as long as you know what you're doing. Join us for a quick look and some best practices in this short course.
30 min
Document Management
QMS
Quality Management
Initial QMS Procedures
Product Development
QMS Refinement & Regulatory Submissions
BOMs
Course
An Overview of Biocompatibility for Medical Devices
Do all devices need to worry about biocompatibility? What does this topic include anyway? Let's answer these questions and more in this short course.
0 hr 32 min
EU MDR
IVDR
ISO 13485
FDA
biocompatibility
Quality Management
Regulatory Management
Initial QMS Procedures
QMS Refinement & Regulatory Submissions
Course
An Overview of UDI Requirements for MedTech
Gain a high level understanding of UDI requirements and some insight into keeping up in the future.
30 min
EU MDR
FDA
UDI
Quality Management
Regulatory Management
QMS Refinement & Regulatory Submissions
Course
Product Development and Engineering Checkpoint Alpha
We are so excited you are on this journey with us! Unlock this course after completing Path 1 from the Product Development and Engineering collection and earn your Specialist Badge.
Currently Unavailable
Advance Exclusive
3 Systems of Risk for Medical Devices
Learn about the 3 systems of risk the FDA may use when evaluating your device submission and how you can manage each one.
Risk Management
Ideation & Prototyping
Initial QMS Procedures
Product Development
QMS Refinement & Regulatory Submissions
Advance Exclusive
Podcast
How to Embrace Risk for Safer Devices
Check out one of our favorite podcast episodes from the Global Medical Device Podcast with Tim Moulton, Founder and President at Motim Industries
Risk Management
Ideation & Prototyping
Product Development
QMS Refinement & Regulatory Submissions
Standard (Free)
Podcast
How Risk Management Can Help Drive Innovation
A session by Michael Quinn, Vice President of Design and Engineering at HS Design
0 hr 46 min
Ideation & Prototyping
Product Development
Webinar
An Overview of Design Controls
What are Design Controls? What do the various regulations require in regards to Design Controls? These answers and more are available in this course so let's get started!
0 hr 28 min
Design Controls
ISO 13485
Ideation & Prototyping
Product Development
Course
An Overview of Risk Management
Learn about risk management for medical devices.
0 hr 28 min
Risk Management
ISO 14971
Ideation & Prototyping
Initial QMS Procedures
Product Development
QMS Refinement & Regulatory Submissions
Product Launch
Standard (Free)
Course
A Step-By-Step Guide to Determine how your Medical Device will be Classified
In this guide, I will provide you with a step-by-step approach for determining how your medical device will be classified by U.S. FDA, the European Commission, and Health Canada. Getting a basic understanding of regulatory product classification will be invaluable to your efforts to bring new products to market.
Device Classification
Ideation & Prototyping
Initial QMS Procedures
Product Development
QMS Refinement & Regulatory Submissions
Advance Exclusive
eBook
The Ultimate Guide to Design Controls for Medical Device Companies
With this guide, Greenlight Guru founder Jon Speer shares valuable insights to explain what Design Controls are, how to address them, and how they benefit your medical device product development efforts.
Currently Unavailable
Design Controls
ISO 13485
Ideation & Prototyping
Product Development
Advance Exclusive
eBook
What is a Medical Device?
What actually counts as a medical device? Are there different types of medical devices? How do I begin to know what my regulatory path will be? Get the answers to these questions and more in this course!
0 hr 42 min
EU MDR
ISO 13485
Device Classification
510(k)
FDA
SAMD
Ideation & Prototyping
Course
Documenting Risk Management to Meet Requirements of ISO 14971:2019
A session by Edwin Bills, Consultant
0 hr 50 min
ISO 14971
Regulatory Management
Initial QMS Procedures
Product Development
QMS Refinement & Regulatory Submissions
Product Launch
Post-Market Surveillance
Standard (Free)
Webinar
The New MDR: Is it Really New and Do We Really Need It?
A session by Mike Drues Ph.D., President at Vascular Sciences
1 hr 5 min
Initial QMS Procedures
QMS Refinement & Regulatory Submissions
Product Launch
Webinar
MDR with Brexit: How the Combination is Impacting the European Medical Device Industry
In this presentation we will be discussing the status of the medical device industry regarding MDR and Brexit, and what are others doing to get ready.
0 hr 53 min
Webinar
Prepare Now for the EUDAMED UDI/Registration Module
UDI data requirement experts Gary Saner and John Lorenc of Reed Tech will discuss best practices for UDI preparations for the upcoming EUDAMED UDI/Registration Module.
0 hr 59 min
Initial QMS Procedures
QMS Refinement & Regulatory Submissions
Product Launch
Webinar
Effective Post-market Surveillance in the EU under MDR
Check out this engaging discussion if you are looking to know more about how EUMDR is changing post-market surveillance.
0 hr 51 min
QMS Refinement & Regulatory Submissions
Product Launch
Post-Market Surveillance
Advance Exclusive
Webinar
The Intersection of Medical Device Usability and Risk Management
Mike Drues joins the podcast again to talk some more about Risk Management
Risk Management
ISO 14971
Product Development
QMS Refinement & Regulatory Submissions
Standard (Free)
Podcast
Risk Management According to EU MDR or ISO 14971?
A session by Peter Sebelius, Founder at Medical Device HQ
0 hr 53 min
ISO 14971
Regulatory Management
Ideation & Prototyping
Product Development
QMS Refinement & Regulatory Submissions
Product Launch
Standard (Free)
Essentials for Clinical Evaluation of Medical Devices
The Globiox team will discuss how the latest updates to EU MDR & IVDR may impact your approach to post-market clinical follow-ups, how to optimally demonstrate equivalency in your report, and how to establish a continuous follow-up process for post-market.
0 hr 53 min
Initial QMS Procedures
QMS Refinement & Regulatory Submissions
Clinical
Standard (Free)
Webinar
The Road to 2024: Regulatory Risks Related to Changed Post-Market Surveillance Requirements and Notified Body Certification
The presentation examines the post-Date of Application period, including - The MDR has more detailed formal PMS requirements.
0 hr 51 min
Regulatory Management
QMS Refinement & Regulatory Submissions
Standard (Free)
Webinar
Economic Operators: Implementation Challenges and Opportunities
Learn about the changing responsibilities for Economic Operators in the medical device industry and how to turn compliance into opportunities for your business.
0 hr 53 min
Initial QMS Procedures
QMS Refinement & Regulatory Submissions
Product Launch
Advance Exclusive
Webinar
Protecting your Data from Risk: To, From, and In the Cloud
A session by Chris DuPont, CEO at Galen Data
Currently Unavailable
0 hr 45 min
Ideation & Prototyping
Product Development
QMS Refinement & Regulatory Submissions
Product Launch
Post-Market Surveillance
Advance Exclusive
Webinar
Applying a Risk-Based Approach to Biological Evaluation of Medical Devices Based on the Framework of ISO 10993-1:2018
What does ISO 10993 require and what are some best practices when applying risk to these evaluations? Learn more from our partner Nelson Labs in this discussion.
0 hr 48 min
Product Development
QMS Refinement & Regulatory Submissions
Advance Exclusive
Webinar
Documenting Risk Management to Meet Requirements of ISO 14971:2019
A session by Edwin Bills, Consultant
0 hr 50 min
ISO 14971
Regulatory Management
Initial QMS Procedures
Product Development
QMS Refinement & Regulatory Submissions
Product Launch
Post-Market Surveillance
Standard (Free)
Webinar
Regulatory Affairs Checkpoint Charlie
You've gone from a Specialist to an Authority and you aren't done yet! Complete the courses in Level 3 and visit this checkpoint to get your Expert badge!
Currently Unavailable
Advance Exclusive
Raising Capital for Medical Device Startups
This course offers an insight into what investors are looking for from founders to feel confident investing. This is a great course for early stage founders thinking about raising their first, or next, round of funding.
30 min
Funding
Ideation & Prototyping
Post-Market Surveillance
Course
A Resource Pack for the MedTech Entrepreneur
Never leave home without it! These resources are always great to have on hand as you plan and execute you next great MedTech idea.
Template
Ideation & Prototyping
Initial QMS Procedures
Advance Exclusive
eBook
Mindset Tools for High Performance Teams
Currently Unavailable
0 hr 31 min
Advance Exclusive
Webinar
CEO Roundtable: Leading Your MedTech Company in 2023 and Beyond
0 hr 37 min
Advance Exclusive
Webinar
Concept to Commercialization Panel
0 hr 41 min
Advance Exclusive
Webinar
Building Companies and Careers: Your Brand
Currently Unavailable
0 hr 41 min
Advance Exclusive
Webinar
From Concept to Commercialization: Introduction to Medical Device Development
So you have an idea for a medical device...what now? This course gives a quick overview of the process of developing a medical device and offers a few practical examples from our experiences in the industry.
0 hr 32 min
EU MDR
QMS
FDA
Ideation & Prototyping
Initial QMS Procedures
Product Development
QMS Refinement & Regulatory Submissions
Product Launch
Post-Market Surveillance
Course
Building the Business Case
Learn why it's important to be able to articulate your business plan and some best practices specific to the medical device industry.
Currently Unavailable
0 hr 20 min
Ideation & Prototyping
QMS Refinement & Regulatory Submissions
Advance Exclusive
Webinar
Building a Regulatory Strategy
Your Regulatory Strategy is a lot more than just jumping through "regulatory hoops". It's your strategic pathway to getting a safe and effective device to market. It could even help you get funding if you have a solid foundation to show potential investors. Let's learn more in this course.
1 hr 14 min
Regulatory Management
Initial QMS Procedures
QMS Refinement & Regulatory Submissions
Advance Exclusive
Webinar
Perfecting the Pitch: Fundraising Roundtable of Early Stage Investors
About to pitch your device to investors or want to be more prepared next time you do? This panel discussion is for you!
Currently Unavailable
0 hr 49 min
Funding
Ideation & Prototyping
Product Development
Advance Exclusive
Webinar
Future of Quality Panel
MedTech leaders answer questions and discuss the future of quality in the medical device industry. Hear what the experts think is just on the horizon!
Currently Unavailable
0 hr 29 min
Quality Management
Advance Exclusive
Webinar
Entrepreneur's Guide Welcome Course
Limited Availability
Developing a New Clinically Relevant ICU Ventilator Fast
A session by John Walmsley, VP of Strategic Partnerships at Starfish Medical. Learn what the urgent need created by the Covid 19 pandemic can teach us about creating viable medical devices more quickly.
0 hr 37 min
Ideation & Prototyping
Product Development
QMS Refinement & Regulatory Submissions
Product Launch
Post-Market Surveillance
Advance Exclusive
Clinical
Webinar
15 Steps to Creating a Risk-Based CAPA Process
This PDF and infographic will have you implementing risk in your CAPA process in no time.
Initial QMS Procedures
QMS Refinement & Regulatory Submissions
Product Launch
Post-Market Surveillance
Advance Exclusive
How to Meet Cybersecurity Requirements of EU MDR & IVDR
EU MDR and IVDR are changing and cybersecurity requirements are no exception. Get the details in this important discussion with Justin from TUV SUD.
Currently Unavailable
0 hr 54 min
Initial QMS Procedures
Product Development
QMS Refinement & Regulatory Submissions
Advance Exclusive
Webinar
Who Owns Risk Management and How Does it Impact the Business?
A session by Jon Speer, Founder at Greenlight Guru
1 hr 1 min
Ideation & Prototyping
Product Development
Function
Webinar
3 Systems of Risk for Medical Devices
Learn about the 3 systems of risk the FDA may use when evaluating your device submission and how you can manage each one.
Risk Management
Ideation & Prototyping
Initial QMS Procedures
Product Development
QMS Refinement & Regulatory Submissions
Advance Exclusive
Podcast
Risk Management from a Regulatory and Product Development Perspective
Another favorite podcast episode with our frequent guest Mike Drues, Ph.D.
Currently Unavailable
Risk Management
Regulatory Management
Product Development
QMS Refinement & Regulatory Submissions
Advance Exclusive
Podcast
A Complete Guide to 21 CFR Part 11
In this comprehensive guide, we’ll take you through each section of 21 CFR Part 11, explaining what the requirements actually mean and expounding the most important points for you to know as a medical device company.
Initial QMS Procedures
QMS Refinement & Regulatory Submissions
Advance Exclusive
eBook
Managing Changes to Medical Device QMS
This white paper provides an overview into some of the major changes happening right now, and provides some recommendations to consider when managing these changes. It covers changes to ISO 13485:2016, the EU Medical Device Regulation and In Vitro Diagnostic Device Regulation.
EU MDR
IVDR
ISO 13485
Initial QMS Procedures
Post-Market Surveillance
eBook
The Ultimate Guide to CAPA
This guide will provide you with best practices and ways to improve your CAPA process and approach so that you can ultimately ensure the medical devices you design, develop, manufacture, and sell will be as safe and effective as possible for those patients that depend upon them.
Currently Unavailable
CAPA
QMS
Product Launch
Post-Market Surveillance
Advance Exclusive
eBook
Risk Management for Executives: Why Does it Matter to Me?
A session by Michael Cremeans, Life Sciences Industry Practice Leader at Hylant
0 hr 44 min
Webinar
The Who, What, and When of IVDR Enforcement
A session by Joanne Lebrun, Vice President at MDC Associates Inc.
Currently Unavailable
0 hr 52 min
EU MDR
Post-Market Surveillance
Advance Exclusive
Webinar
3 Keys to Successful Internal Audits
Gurus Taylor Brown and Sara Adams discuss their top 3 ways to have better internal audits in this quick video
0 hr 4 min
Audit
Initial QMS Procedures
QMS Refinement & Regulatory Submissions
Product Launch
Post-Market Surveillance
Advance Exclusive
Webinar
Quality Assurance Management Checkpoint Beta
You're graduating to the level of "Authority". You know your stuff and it's time you got a shiny new badge to prove it. Check-in here and you'll be ready to move on to level 3!
Currently Unavailable
Advance Exclusive
Overview of CAPA
The CAPA process is almost always a topic of audits and inspections and regularly one of the top reasons for medical device submissions to be rejected by regulatory bodies. Learn what this process is and why it's so important to creating safer and better medical devices.
0 hr 17 min
CAPA
Initial QMS Procedures
QMS Refinement & Regulatory Submissions
Product Launch
Post-Market Surveillance
Advance Exclusive
Course
Building a Regulatory Strategy
Your Regulatory Strategy is a lot more than just jumping through "regulatory hoops". It's your strategic pathway to getting a safe and effective device to market. It could even help you get funding if you have a solid foundation to show potential investors. Let's learn more in this course.
1 hr 14 min
Regulatory Management
Initial QMS Procedures
QMS Refinement & Regulatory Submissions
Advance Exclusive
Webinar
A Step-By-Step Guide to Determine how your Medical Device will be Classified
In this guide, I will provide you with a step-by-step approach for determining how your medical device will be classified by U.S. FDA, the European Commission, and Health Canada. Getting a basic understanding of regulatory product classification will be invaluable to your efforts to bring new products to market.
Device Classification
Ideation & Prototyping
Initial QMS Procedures
Product Development
QMS Refinement & Regulatory Submissions
Advance Exclusive
eBook
How to Embrace Risk for Safer Devices
Check out one of our favorite podcast episodes from the Global Medical Device Podcast with Tim Moulton, Founder and President at Motim Industries
Risk Management
Ideation & Prototyping
Product Development
QMS Refinement & Regulatory Submissions
Standard (Free)
Podcast
The Beginners Guide to Design Verification and Design Validation for Medical Devices
In this guide, we’ll go through the basics of design verification, design validation, best practices you should deploy, pitfalls you should avoid, and plans that will make it all come together.
Currently Unavailable
Design Controls
Product Development
QMS Refinement & Regulatory Submissions
Advance Exclusive
eBook
A Step-By-Step Guide to Preparing your FDA 510(k) Submission
Get ready to submit your 510(k) with advice from our industry experts
Document Management
Design Controls
Change Management
Device Classification
QMS
510(k)
Product Development
QMS Refinement & Regulatory Submissions
Advance Exclusive
eBook
An Overview of Risk Management
Learn about risk management for medical devices.
0 hr 28 min
Risk Management
ISO 14971
Ideation & Prototyping
Initial QMS Procedures
Product Development
QMS Refinement & Regulatory Submissions
Product Launch
Standard (Free)
Course
What is a Medical Device?
What actually counts as a medical device? Are there different types of medical devices? How do I begin to know what my regulatory path will be? Get the answers to these questions and more in this course!
0 hr 42 min
EU MDR
ISO 13485
Device Classification
510(k)
FDA
SAMD
Ideation & Prototyping
Course
How to Maintain a QMS Compliant to MDR & IVDR
Your QMS should be your source of truth, but what happens when the requirements for a QMS change? Get equipped to meet EUMDR and IVDR standards by checking out this talk from Kyle Rose.
0 hr 52 min
Initial QMS Procedures
QMS Refinement & Regulatory Submissions
Post-Market Surveillance
Webinar
Risk Management from a Regulatory and Product Development Perspective
Another favorite podcast episode with our frequent guest Mike Drues, Ph.D.
Currently Unavailable
Risk Management
Regulatory Management
Product Development
QMS Refinement & Regulatory Submissions
Advance Exclusive
Podcast
Standards and Pathways to the EU Medical Device Market
There have been many changes to the process of bringing a medical device to market in the EU. This course will highlight a bit of that history as well as best practices for the current state of the EU MDR.
0 hr 42 min
EU MDR
Device Classification
QMS
Initial QMS Procedures
Product Development
QMS Refinement & Regulatory Submissions
Course
A Complete Guide to Bringing a Medical Device to Market
A complete guide for medical device manufacturers looking for guidance on how to plan for a successful product launch and maintain regulatory compliance across global markets.
Risk Management
Design Controls
QMS
Ideation & Prototyping
Initial QMS Procedures
Product Development
QMS Refinement & Regulatory Submissions
Product Launch
Post-Market Surveillance
Advance Exclusive
eBook
Standards and Pathways to the USA Medical Device Market
Anyone looking to launch a medical device into the United States market should be familiar with the FDA and the regulations they use. This course will give you a look at the regulations themselves and a little history on the FDA and how it came to be.
0 hr 42 min
Device Classification
QMS
510(k)
FDA
Initial QMS Procedures
Product Development
QMS Refinement & Regulatory Submissions
Course
Regulatory Affairs Checkpoint Alpha
We are so excited you are on this journey with us! Unlock this course after completing Path 1 from the collection and earn your Specialist Badge.
Currently Unavailable
Advance Exclusive
How to Create Medical Device Labels per EU MDR
A session by Monir El Azzouzi, Founder and CEO at Easy Medical Device
Currently Unavailable
0 hr 55 min
Initial QMS Procedures
Product Development
QMS Refinement & Regulatory Submissions
Product Launch
Advance Exclusive
Webinar
A Step-By-Step Guide to Preparing your FDA 510(k) Submission
Get ready to submit your 510(k) with advice from our industry experts
Document Management
Design Controls
Change Management
Device Classification
QMS
510(k)
Product Development
QMS Refinement & Regulatory Submissions
Advance Exclusive
eBook
From Self-Declaration to Certification: Proving Performance Under IVDR
Learn best practices around proving performance under the new IVDR requirements.
Currently Unavailable
0 hr 54 min
Product Development
QMS Refinement & Regulatory Submissions
Advance Exclusive
Webinar
How to Meet Cybersecurity Requirements of EU MDR & IVDR
EU MDR and IVDR are changing and cybersecurity requirements are no exception. Get the details in this important discussion with Justin from TUV SUD.
Currently Unavailable
0 hr 54 min
Initial QMS Procedures
Product Development
QMS Refinement & Regulatory Submissions
Advance Exclusive
Webinar
The Risk Management + Design Controls Connection: What Device Makers Need to Know
Greenlight Guru found Jon Speer discusses why design controls and risk management should flow and blend together, and it’s important to establish this flow early in product development.
Risk Management
Design Controls
Product Development
Standard (Free)
eBook
Risk Management According to EU MDR or ISO 14971?
A session by Peter Sebelius, Founder at Medical Device HQ
0 hr 53 min
ISO 14971
Regulatory Management
Ideation & Prototyping
Product Development
QMS Refinement & Regulatory Submissions
Product Launch
Standard (Free)
Product Development and Engineering Checkpoint Charlie
You've gone from a Specialist to an Authority and you aren't done yet! Complete the courses in Level 3 and visit this checkpoint to get your Expert badge!
Currently Unavailable
Advance Exclusive
Design Controls, Development, and Risk for SaMD
Many elements of medical device development are different for software devices. Learn the key differentiators and best practices for developing these exciting device types.
Risk Management
Design Controls
SAMD
Ideation & Prototyping
Product Development
Advance Exclusive
Podcast
The Beginners Guide to Design Verification and Design Validation for Medical Devices
In this guide, we’ll go through the basics of design verification, design validation, best practices you should deploy, pitfalls you should avoid, and plans that will make it all come together.
Currently Unavailable
Design Controls
Product Development
QMS Refinement & Regulatory Submissions
Advance Exclusive
eBook
The Art of Defining Design Inputs and Design Outputs
The art of defining design inputs & design outputs for FDA compliance by medical device manufacturers.
Currently Unavailable
Design Controls
QMS
Product Development
Advance Exclusive
eBook
Challenges with Applying Risk Management Throughout the Manufacturing Process
Every medical device developer has to understand risk management. You could learn the hard way, or you could listen to our experts share their trials and successes on this important topic.
Risk Management
ISO 14971
manufacturing
Product Development
Product Launch
Post-Market Surveillance
Advance Exclusive
Podcast
Implementing and Maintaining Changes to SaMD Under MDR
This session will cover the outline of MDR requirements for SaMD, including qualification and classification, clinical evaluation and expanded post-market activities among others.
Currently Unavailable
0 hr 51 min
Product Development
QMS Refinement & Regulatory Submissions
Advance Exclusive
Webinar
How to Prepare for Common MDR Audit Pitfalls
A session by Bassil Akra, CEO and Co-Owner, QUNIQUE GmbH
0 hr 53 min
Initial QMS Procedures
QMS Refinement & Regulatory Submissions
Product Launch
Post-Market Surveillance
Standard (Free)
Webinar
Risks that No One Wants to Talk About: Theoretical Risk Management vs. Life in the Real World
A session by Mike Drues Ph.D., President at Vascular Sciences
0 hr 55 min
Initial QMS Procedures
Product Development
QMS Refinement & Regulatory Submissions
Product Launch
Standard (Free)
Webinar
The Ultimate Guide to ISO 13485:2016 Quality Management System for Medical Devices
In this guide you'll learn about ISO 13485 and why Greenlight Guru founder Jon Speer believes that a QMS should be a set of processes that help you to run a better, more efficient business that focuses on true quality and what is best for the patients who will be recipients of your medical devices.
Currently Unavailable
ISO 13485
QMS
Initial QMS Procedures
Post-Market Surveillance
Advance Exclusive
eBook
Overview of Nonconformance
This course will help you understand what nonconformance means in the medical device industry, what is required by regulating bodies, and how a well managed nonconformance process will help you make safer and more effective devices.
0 hr 17 min
Nonconformance
Initial QMS Procedures
QMS Refinement & Regulatory Submissions
Product Launch
Post-Market Surveillance
Advance Exclusive
Course
The Ultimate Guide to Document Control for Medical Device Companies
This in-depth guide will take a deep dive into the problems that tend to afflict document control activities, provide detailed explanations of the procedures that make your documentation more efficient, and offer proven effective methods for implementing and leveraging a robust document management system that will catapult the success of your organization and medical device.
Currently Unavailable
Document Management
Change Management
ISO 13485
QMS
Initial QMS Procedures
Post-Market Surveillance
Advance Exclusive
eBook
Protecting your Data from Risk: To, From, and In the Cloud
A session by Chris DuPont, CEO at Galen Data
Currently Unavailable
0 hr 45 min
Ideation & Prototyping
Product Development
QMS Refinement & Regulatory Submissions
Product Launch
Post-Market Surveillance
Advance Exclusive
Webinar
What to do when FMEA is Not Sufficient Anymore
A session by Peter Sebelius, Founder at Medical Device HQ
0 hr 48 min
Product Development
Standard (Free)
Webinar
Managing Risks Along an IVD-Analyzer's Life-Cycle
A session by Christopher Schar, Senior Consultant with QUNIQUE
Currently Unavailable
0 hr 44 min
Advance Exclusive
Webinar
Quality Assurance Management Checkpoint Charlie
You've gone from a Specialist to an Authority and you aren't done yet! Complete the courses in Level 3 and visit this checkpoint to get your Expert badge!
Currently Unavailable
Advance Exclusive
Implementation of the Risk Management Board for New Product Introduction and Post Market Surveillance
A session by Mike Baca, President at White Rook Consulting
Currently Unavailable
0 hr 46 min
Product Development
QMS Refinement & Regulatory Submissions
Advance Exclusive
Webinar
Challenges with Applying Risk Management Throughout the Manufacturing Process
Every medical device developer has to understand risk management. You could learn the hard way, or you could listen to our experts share their trials and successes on this important topic.
Risk Management
ISO 14971
manufacturing
Product Development
Product Launch
Post-Market Surveillance
Advance Exclusive
Podcast
Change Management and Risk Management: How do we connect the dots and what happens if we don't?
Change management and risk management should work together, but it does take some work to make that happen. Let us help with these important tips and sage advice from Mike Drues.
Risk Management
Change Management
Initial QMS Procedures
Product Development
Product Launch
Post-Market Surveillance
Advance Exclusive
Webinar
Risks that No One Wants to Talk About: Theoretical Risk Management vs. Life in the Real World
A session by Mike Drues Ph.D., President at Vascular Sciences
0 hr 55 min
Initial QMS Procedures
Product Development
QMS Refinement & Regulatory Submissions
Product Launch
Standard (Free)
Webinar
Who Owns Risk Management and How Does it Impact the Business?
A session by Jon Speer, Founder at Greenlight Guru
1 hr 1 min
Ideation & Prototyping
Product Development
Function
Webinar
Risk Management for Executives: Why Does it Matter to Me?
A session by Michael Cremeans, Life Sciences Industry Practice Leader at Hylant
0 hr 44 min
Webinar
What is the Best Way to Structure a Risk Management File
A session by Carolyn Guthrie, Director QA/RA at Kapstone Medical
Currently Unavailable
0 hr 48 min
Initial QMS Procedures
Product Development
Advance Exclusive
Webinar
Risk Management from a Regulatory and Product Development Perspective
Another favorite podcast episode with our frequent guest Mike Drues, Ph.D.
Currently Unavailable
Risk Management
Regulatory Management
Product Development
QMS Refinement & Regulatory Submissions
Advance Exclusive
Podcast
The Intersection of Medical Device Usability and Risk Management
Mike Drues joins the podcast again to talk some more about Risk Management
Risk Management
ISO 14971
Product Development
QMS Refinement & Regulatory Submissions
Standard (Free)
Podcast
Ultimate guide to Agile Design and Development for Medical Devices
In this guide, we discuss how the Agile Method for Medical Device Design is an iterative process that includes all products and product features that are tested, verified and validated, and allows for tweaks, requirement changes, risk updates and compliance updates as needed.
Currently Unavailable
Risk Management
Document Management
Design Controls
Change Management
Ideation & Prototyping
Product Development
Advance Exclusive
eBook
The Definitive Guide to Change Management for Medical Devices
This guide will detail the change management best practices that medical device companies need to understand and follow when making changes to documents, products, processes, and more.
Currently Unavailable
Document Management
Change Management
Initial QMS Procedures
Product Launch
Post-Market Surveillance
Advance Exclusive
eBook
Product Development and Engineering Checkpoint Delta
What an accomplishment! You spent the time, invested in your own knowledge, and now it's time to celebrate. Now hop in here and get your Guru Badge, so you can show off a little.
Currently Unavailable
Advance Exclusive
Implementing and Maintaining Changes to SaMD Under MDR
This session will cover the outline of MDR requirements for SaMD, including qualification and classification, clinical evaluation and expanded post-market activities among others.
Currently Unavailable
0 hr 51 min
Product Development
QMS Refinement & Regulatory Submissions
Advance Exclusive
Webinar
3 Systems of Risk for Medical Devices
Learn about the 3 systems of risk the FDA may use when evaluating your device submission and how you can manage each one.
Risk Management
Ideation & Prototyping
Initial QMS Procedures
Product Development
QMS Refinement & Regulatory Submissions
Advance Exclusive
Podcast
Challenges with Applying Risk Management Throughout the Manufacturing Process
Every medical device developer has to understand risk management. You could learn the hard way, or you could listen to our experts share their trials and successes on this important topic.
Risk Management
ISO 14971
manufacturing
Product Development
Product Launch
Post-Market Surveillance
Advance Exclusive
Podcast
Change Management and Risk Management: How do we connect the dots and what happens if we don't?
Change management and risk management should work together, but it does take some work to make that happen. Let us help with these important tips and sage advice from Mike Drues.
Risk Management
Change Management
Initial QMS Procedures
Product Development
Product Launch
Post-Market Surveillance
Advance Exclusive
Webinar
FDA 510(k) Overview
Get to know this common FDA clearance path and understand when you'll need to use it.
0 hr 34 min
510(k)
Initial QMS Procedures
Product Development
QMS Refinement & Regulatory Submissions
Course
Regulatory Affairs Checkpoint Beta
You're graduating to the level of "Authority". You know your stuff and it's time you got a shiny new badge to prove it. Check-in here and you'll be ready to move on to level 3!
Currently Unavailable
Advance Exclusive
MDR Date of Application Roundup: The New Landscape for Medical Device Manufacturers
A session by Evangeline Loh, VP of Regulatory Affairs at Emergo by UL
0 hr 47 min
Product Development
QMS Refinement & Regulatory Submissions
Post-Market Surveillance
Standard (Free)
Webinar
Evaluating need for Biocompatibility Testing & Mitigating Risks when Changing your Medical Device
When you want to know more about biocompatibility, you go to the experts! Hear Thor Rollins of Nelson Labs discuss this crucial topic about the intersection of risk, biocompatibility, and change management.
Currently Unavailable
Risk Management
Change Management
Initial QMS Procedures
Product Development
QMS Refinement & Regulatory Submissions
Advance Exclusive
Webinar
Europe's First Device Regulations: A Look Into Manufacturers' Response to the Delay, Transition, & Implementation Process
Jon Speer, Founder of Greenlight Guru, will dive into key data and findings from Greenlight Guru's upcoming EU MDR Report, which surveyed hundreds of medical device professionals from all over the world.
0 hr 57 min
QMS Refinement & Regulatory Submissions
Product Launch
Post-Market Surveillance
Standard (Free)
Webinar
From Self-Declaration to Certification: Proving Performance Under IVDR
Learn best practices around proving performance under the new IVDR requirements.
Currently Unavailable
0 hr 54 min
Product Development
QMS Refinement & Regulatory Submissions
Advance Exclusive
Webinar
A Complete Guide to 21 CFR Part 11
In this comprehensive guide, we’ll take you through each section of 21 CFR Part 11, explaining what the requirements actually mean and expounding the most important points for you to know as a medical device company.
Initial QMS Procedures
QMS Refinement & Regulatory Submissions
Advance Exclusive
eBook
Addressing the Notified Body Bottleneck
This presentation explores the current state of notified body designation and how companies can navigate existing and anticipated scarcity.
0 hr 56 min
Product Development
QMS Refinement & Regulatory Submissions
Advance Exclusive
Webinar
CE Mark Technical Documentation: Changes, Application, and Notified Body Expectations under MDR
This presentation will provide an overview of the technical documentation requirements under MDR including format and content.
0 hr 54 min
Initial QMS Procedures
Product Development
QMS Refinement & Regulatory Submissions
Advance Exclusive
Webinar
The Definitive Guide to Change Management for Medical Devices
This guide will detail the change management best practices that medical device companies need to understand and follow when making changes to documents, products, processes, and more.
Currently Unavailable
Document Management
Change Management
Initial QMS Procedures
Product Launch
Post-Market Surveillance
Advance Exclusive
eBook
Change Management and Risk Management: How do we connect the dots and what happens if we don't?
Change management and risk management should work together, but it does take some work to make that happen. Let us help with these important tips and sage advice from Mike Drues.
Risk Management
Change Management
Initial QMS Procedures
Product Development
Product Launch
Post-Market Surveillance
Advance Exclusive
Webinar
Product Development and Engineering Checkpoint Beta
You're graduating to the level of "Authority". You know your stuff and it's time you got a shiny new badge to prove it. Check-in here and you'll be ready to move on to level 3!
Currently Unavailable
Advance Exclusive
A Complete Guide to 21 CFR Part 11
In this comprehensive guide, we’ll take you through each section of 21 CFR Part 11, explaining what the requirements actually mean and expounding the most important points for you to know as a medical device company.
Initial QMS Procedures
QMS Refinement & Regulatory Submissions
Advance Exclusive
eBook
How and When to Conduct your First Hazard Analysis
A session by Sarah Nixon, Quality Engineer with Rook Quality Systems
Currently Unavailable
0 hr 45 min
Ideation & Prototyping
Product Development
Advance Exclusive
Webinar
How to Implement Risk Management into Regulatory Submissions Using Tips, Tricks, and Standards to Satisfy FDA Concerns
A session by Mary McNamara-Cullinane. Senior Vice President of Regulatory Affairs, Alira Health.
0 hr 47 min
Product Development
QMS Refinement & Regulatory Submissions
Standard (Free)
Webinar
From Concept to Commercialization: Introduction to Medical Device Development
So you have an idea for a medical device...what now? This course gives a quick overview of the process of developing a medical device and offers a few practical examples from our experiences in the industry.
0 hr 32 min
EU MDR
QMS
FDA
Ideation & Prototyping
Initial QMS Procedures
Product Development
QMS Refinement & Regulatory Submissions
Product Launch
Post-Market Surveillance
Course
Standards and Pathways to the EU Medical Device Market
There have been many changes to the process of bringing a medical device to market in the EU. This course will highlight a bit of that history as well as best practices for the current state of the EU MDR.
0 hr 42 min
EU MDR
Device Classification
QMS
Initial QMS Procedures
Product Development
QMS Refinement & Regulatory Submissions
Course
Standards and Pathways to the USA Medical Device Market
Anyone looking to launch a medical device into the United States market should be familiar with the FDA and the regulations they use. This course will give you a look at the regulations themselves and a little history on the FDA and how it came to be.
0 hr 42 min
Device Classification
QMS
510(k)
FDA
Initial QMS Procedures
Product Development
QMS Refinement & Regulatory Submissions
Course
A Complete Guide to Bringing a Medical Device to Market
A complete guide for medical device manufacturers looking for guidance on how to plan for a successful product launch and maintain regulatory compliance across global markets.
Risk Management
Design Controls
QMS
Ideation & Prototyping
Initial QMS Procedures
Product Development
QMS Refinement & Regulatory Submissions
Product Launch
Post-Market Surveillance
Advance Exclusive
eBook
Essentials of Software as a Medical Device
With software being a growing industry, in general, it is no surprise that this popularity is making its way to medical devices. This course will give a quick overview of what we mean by Software as a Medical Device as well as what the regulations say about it and how it differs from other medical device development.
$100
0 hr 42 min
SAMD
Initial QMS Procedures
Product Development
QMS Refinement & Regulatory Submissions
Software
Cybersecurity
Course
FDA 510(k) Overview
Get to know this common FDA clearance path and understand when you'll need to use it.
0 hr 34 min
510(k)
Initial QMS Procedures
Product Development
QMS Refinement & Regulatory Submissions
Course
The Who, What, and When of IVDR Enforcement
A session by Joanne Lebrun, Vice President at MDC Associates Inc.
Currently Unavailable
0 hr 52 min
EU MDR
Post-Market Surveillance
Advance Exclusive
Webinar
Implementing and Maintaining Changes to SaMD Under MDR
This session will cover the outline of MDR requirements for SaMD, including qualification and classification, clinical evaluation and expanded post-market activities among others.
Currently Unavailable
0 hr 51 min
Product Development
QMS Refinement & Regulatory Submissions
Advance Exclusive
Webinar
How to Implement Risk Management into Regulatory Submissions Using Tips, Tricks, and Standards to Satisfy FDA Concerns
A session by Mary McNamara-Cullinane. Senior Vice President of Regulatory Affairs, Alira Health.
0 hr 47 min
Product Development
QMS Refinement & Regulatory Submissions
Standard (Free)
Webinar
How to Meet Cybersecurity Requirements of EU MDR & IVDR
EU MDR and IVDR are changing and cybersecurity requirements are no exception. Get the details in this important discussion with Justin from TUV SUD.
Currently Unavailable
0 hr 54 min
Initial QMS Procedures
Product Development
QMS Refinement & Regulatory Submissions
Advance Exclusive
Webinar
Significant Risk vs. Nonsignificant Risk Devices - What's the Difference?
Check out one of our favorite podcast episodes from the Global Medical Device Podcast with Mike Drues, Ph.D.
Currently Unavailable
Risk Management
Ideation & Prototyping
Initial QMS Procedures
Product Development
QMS Refinement & Regulatory Submissions
Advance Exclusive
Podcast
UDI and Device Registration, Another Launch Checkbox
A session by Gary Saner, Sr Mgr of Information Solutions at Reed Tech
0 hr 49 min
UDI
QMS Refinement & Regulatory Submissions
Post-Market Surveillance
Webinar
The Definitive Guide to Responding to FDA 483 and Warning Letters
This guide will go into great detail regarding exactly how to respond to FDA 483 observations and warning letters.
Currently Unavailable
Initial QMS Procedures
QMS Refinement & Regulatory Submissions
Post-Market Surveillance
Advance Exclusive
eBook
How to Create Medical Device Labels per EU MDR
A session by Monir El Azzouzi, Founder and CEO at Easy Medical Device
Currently Unavailable
0 hr 55 min
Initial QMS Procedures
Product Development
QMS Refinement & Regulatory Submissions
Product Launch
Advance Exclusive
Webinar
Risks that No One Wants to Talk About: Theoretical Risk Management vs. Life in the Real World
A session by Mike Drues Ph.D., President at Vascular Sciences
0 hr 55 min
Initial QMS Procedures
Product Development
QMS Refinement & Regulatory Submissions
Product Launch
Standard (Free)
Webinar
How to Predict Medical Device Recalls using Publicly Available Data
A session by Mohammed (Bilash) Hossain and John Lorenc of Reed Tech
Currently Unavailable
0 hr 45 min
QMS Refinement & Regulatory Submissions
Post-Market Surveillance
Advance Exclusive
Webinar
Risk Management for Executives: Why Does it Matter to Me?
A session by Michael Cremeans, Life Sciences Industry Practice Leader at Hylant
0 hr 44 min
Webinar
Regulatory Affairs Checkpoint Delta
What an accomplishment! You spent the time, invested in your own knowledge, and now it's time to celebrate. Now hop in here and get your Guru Badge, so you can show off a little.
Currently Unavailable
Advance Exclusive
What Role Should Quality Play in Bringing a Device to Market?
A session by Jon Speer, Founder at Greenlight Guru
0 hr 50 min
Ideation & Prototyping
Product Launch
Standard (Free)
Webinar
Europe's First Device Regulations: A Look Into Manufacturers' Response to the Delay, Transition, & Implementation Process
Jon Speer, Founder of Greenlight Guru, will dive into key data and findings from Greenlight Guru's upcoming EU MDR Report, which surveyed hundreds of medical device professionals from all over the world.
0 hr 57 min
QMS Refinement & Regulatory Submissions
Product Launch
Post-Market Surveillance
Standard (Free)
Webinar
How to Embrace Risk for Safer Devices
Check out one of our favorite podcast episodes from the Global Medical Device Podcast with Tim Moulton, Founder and President at Motim Industries
Risk Management
Ideation & Prototyping
Product Development
QMS Refinement & Regulatory Submissions
Standard (Free)
Podcast
Documenting Risk Management to Meet Requirements of ISO 14971:2019
A session by Edwin Bills, Consultant
0 hr 50 min
ISO 14971
Regulatory Management
Initial QMS Procedures
Product Development
QMS Refinement & Regulatory Submissions
Product Launch
Post-Market Surveillance
Standard (Free)
Webinar
Essentials for Clinical Evaluation of Medical Devices
The Globiox team will discuss how the latest updates to EU MDR & IVDR may impact your approach to post-market clinical follow-ups, how to optimally demonstrate equivalency in your report, and how to establish a continuous follow-up process for post-market.
0 hr 53 min
Initial QMS Procedures
QMS Refinement & Regulatory Submissions
Clinical
Standard (Free)
Webinar
What is a Medical Device?
What actually counts as a medical device? Are there different types of medical devices? How do I begin to know what my regulatory path will be? Get the answers to these questions and more in this course!
0 hr 42 min
EU MDR
ISO 13485
Device Classification
510(k)
FDA
SAMD
Ideation & Prototyping
Course
An Overview of Risk Management
Learn about risk management for medical devices.
0 hr 28 min
Risk Management
ISO 14971
Ideation & Prototyping
Initial QMS Procedures
Product Development
QMS Refinement & Regulatory Submissions
Product Launch
Standard (Free)
Course
Ultimate Guide to 21 CFR Part 820 - FDA's Quality System Regulation for Medical Devices
Join Medical Device Guru Taylor Brown for a discussion on the requirements of 21 CFR Part 820 and why it might not be as challenging as it first seems to meet those requirements..
Currently Unavailable
Risk Management
Document Management
CAPA
Design Controls
QMS
Initial QMS Procedures
Post-Market Surveillance
Advance Exclusive
eBook
How to Maintain a QMS Compliant to MDR & IVDR
Your QMS should be your source of truth, but what happens when the requirements for a QMS change? Get equipped to meet EUMDR and IVDR standards by checking out this talk from Kyle Rose.
0 hr 52 min
Initial QMS Procedures
QMS Refinement & Regulatory Submissions
Post-Market Surveillance
Webinar
ISO 14971 Risk Management for Medical Devices
Use this guide to align with the latest version of ISO 14971 and to learn additional tips and insights for medical device risk management.
Risk Management
QMS
ISO 14971
Ideation & Prototyping
Initial QMS Procedures
Product Development
QMS Refinement & Regulatory Submissions
Product Launch
Post-Market Surveillance
eBook
The Definitive Guide to Change Management for Medical Devices
This guide will detail the change management best practices that medical device companies need to understand and follow when making changes to documents, products, processes, and more.
Currently Unavailable
Document Management
Change Management
Initial QMS Procedures
Product Launch
Post-Market Surveillance
Advance Exclusive
eBook
Audit Basics
Learn the difference between audits, inspections, and the different types of each you may encounter in the medical device industry.
0 hr 42 min
Audit
EU MDR
ISO 13485
FDA
Initial QMS Procedures
QMS Refinement & Regulatory Submissions
Product Launch
Post-Market Surveillance
Course
Quality Assurance Management Checkpoint Alpha
We are so excited you are on this journey with us! Unlock this course after completing Path 1 from the collection and earn your Specialist Badge.
Currently Unavailable
Advance Exclusive
Planning your Cloud Connectivity Strategy to Reduce Cybersecurity and Privacy Risk
A session by Abbas Dhilawala, CTO at Galen Data
Currently Unavailable
0 hr 45 min
cybersecurity
Product Development
QMS Refinement & Regulatory Submissions
Advance Exclusive
Webinar
Effective Post-market Surveillance in the EU under MDR
Check out this engaging discussion if you are looking to know more about how EUMDR is changing post-market surveillance.
0 hr 51 min
QMS Refinement & Regulatory Submissions
Product Launch
Post-Market Surveillance
Advance Exclusive
Webinar
Supply Chain Management under the MDR, Brexit and Swixit
As a result of the MDR, Brexit and Swixit, manufacturers need to be fully aware of how these changes may impact their current and future supply chain Europe.
0 hr 49 min
Initial QMS Procedures
Product Launch
Post-Market Surveillance
Standard (Free)
Webinar
How to Apply Risk Management Throughout the Product Lifecycle of your Medical Device
A session by Mike Baca, President at White Rook Consulting
Currently Unavailable
0 hr 48 min
Ideation & Prototyping
Initial QMS Procedures
Product Development
QMS Refinement & Regulatory Submissions
Product Launch
Post-Market Surveillance
Advance Exclusive
Webinar
How to Create Medical Device Labels per EU MDR
A session by Monir El Azzouzi, Founder and CEO at Easy Medical Device
Currently Unavailable
0 hr 55 min
Initial QMS Procedures
Product Development
QMS Refinement & Regulatory Submissions
Product Launch
Advance Exclusive
Webinar
Remote audits
This course will cover remote audits, virtual Inspections, and other alternative tools and methods regulators have implemented, particularly during the Covid 19 pandemic.
0 hr 40 min
Audit
EU MDR
ISO 13485
FDA
Initial QMS Procedures
QMS Refinement & Regulatory Submissions
Product Launch
Post-Market Surveillance
Course
Evaluating need for Biocompatibility Testing & Mitigating Risks when Changing your Medical Device
When you want to know more about biocompatibility, you go to the experts! Hear Thor Rollins of Nelson Labs discuss this crucial topic about the intersection of risk, biocompatibility, and change management.
Currently Unavailable
Risk Management
Change Management
Initial QMS Procedures
Product Development
QMS Refinement & Regulatory Submissions
Advance Exclusive
Webinar
Using the Bucket Method for Medical Device Risk Management
Mike Drues joins the podcast again to talk some more about Risk Management
Currently Unavailable
Risk Management
Initial QMS Procedures
Product Development
QMS Refinement & Regulatory Submissions
Product Launch
Advance Exclusive
Podcast
Overview of Complaints
So you got your device to market. Now what? Well one of the major things to be ready for now are complaints. This course will help you understand what is required and share some best practices.
0 hr 17 min
CAPA
FDA
Feedback
Complaints
Initial QMS Procedures
QMS Refinement & Regulatory Submissions
Product Launch
Post-Market Surveillance
Advance Exclusive
Course
Training Management in the Medical Device Industry
Learn what the regulations say about training management and how to best implement it into your QMS in this overview course.
0 hr 28 min
Change Management
Training
ISO 13485
Initial QMS Procedures
Post-Market Surveillance
Standard (Free)
Course
The Ultimate Guide to Training Management for Medical Device Companies
This ultimate guide provides an in-depth look at answers to those common questions and explains everything you need to know to comply with the applicable requirements as well as establish a training management system that promotes total competence of the members of your medical device organization.
Currently Unavailable
Training
ISO 13485
QMS
Initial QMS Procedures
Post-Market Surveillance
Advance Exclusive
eBook
What is the Best Way to Structure a Risk Management File
A session by Carolyn Guthrie, Director QA/RA at Kapstone Medical
Currently Unavailable
0 hr 48 min
Initial QMS Procedures
Product Development
Advance Exclusive
Webinar
Quality Assurance Manager Checkpoint Delta
What an accomplishment! You spent the time, invested in your own knowledge, and now it's time to celebrate. Now hop in here and get your Guru Badge, so you can show off a little.
Limited Availability
Advance Exclusive
Entrepreneur's Guide Welcome Course
Limited Availability
Quality Assurance Manager Checkpoint Delta
What an accomplishment! You spent the time, invested in your own knowledge, and now it's time to celebrate. Now hop in here and get your Guru Badge, so you can show off a little.
Limited Availability
Advance Exclusive
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Greenlight Guru Academy specializes in providing education and training resources for medical device professionals.