Advance Exclusive Membership

Access to hundreds of courses, resources, webinars & more- all included in your membership.

Premium Resources fka Academy Membership
Premium Resources fka Academy Membership
Sign up for Medical Device Learning, Medical Device certifications
Join now! →
Greenlight Guru Academy Success Paths
Greenlight Guru Academy Success Paths
Learning journeys designed for medical device success.
Explore Paths →
Learning Path
Learning Alliances
Learning Alliances
We can't offer every course on the Academy, but we still want to offer value for our members. Check out our hand picked learning partners and what they have to offer if you aren't quite finding what you need through the Academy.
See discounts →
Foundations of Safe Medical Device Development and Manufacturing
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
The Entrepreneur's Guide to the Medical Device Industry
The Entrepreneur's Guide to the Medical Device Industry
$100
13 Courses
Advance Exclusive Course Package 0-$100
The "New" Safety & Performance-Based 510(k)
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
CLIA and Provider-Performed Microscopy (PPM) Procedures: An Introduction
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
Fundamentals of Personal Protective Equipment (PPE) in Clinical Laboratories
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 Clinical Laboratory Improvement Amendments of 1988 (CLIA)
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
Introduction to Laboratory Informatics: Life of a Result
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
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
Introduction to Laboratory Risk Management (LRM)
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
Introduction to the LIMS & Other Information Systems
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
Laboratory Continuity of Operations (COOP) Planning 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
Packing and Shipping Dangerous Goods: What the Laboratory Staff Must Know
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
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
15 Steps to Creating a Risk-Based CAPA Process
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
3 Keys to Successful Internal Audits
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
3 Systems of Risk for Medical Devices
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
A Complete Guide to 21 CFR Part 11
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 Complete Guide to Bringing a Medical Device to Market
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
A Step-By-Step Guide to Determine how your Medical Device will be Classified
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
A Step-By-Step Guide to Preparing your FDA 510(k) Submission
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
Addressing the Notified Body Bottleneck
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
An Overview of Biocompatibility for Medical Devices
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 Human Factors Engineering for MedTech
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
An Overview of UDI Requirements for MedTech
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
Applying a Risk-Based Approach to Biological Evaluation of Medical Devices Based on the Framework of ISO 10993-1:2018
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
Audit Basics
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
Basil Akra: Status of EU MDR and EU IVDR
Basil Akra: Status of EU MDR and EU IVDR
0 hr 40 min
EU MDR IVDR Advance Exclusive Webinar
Behind the Research: Overcoming the Barriers to Improved Quality
Behind the Research: Overcoming the Barriers to Improved Quality
0 hr 46 min
Quality Management Advance Exclusive Webinar
Biocompatibility Evaluation for Device Submission
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
Breakout Session: Best Quality Practices for SaMD, Including AI and ML
Breakout Session: Best Quality Practices for SaMD, Including AI and ML
0 hr 43 min
SAMD Advance Exclusive Webinar
Breakout Session: Communicating with the FDA
Breakout Session: Communicating with the FDA
0 hr 37 min
FDA Advance Exclusive Webinar
Breakout Session: Incorporating Risk Management throughout your Device Lifecycles
Breakout Session: Incorporating Risk Management throughout your Device Lifecycles
0 hr 40 min
Risk Management Advance Exclusive Webinar
Building a Regulatory Strategy
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
Building Companies and Careers: Your Brand
Building Companies and Careers: Your Brand
Currently Unavailable
0 hr 41 min
Advance Exclusive Webinar
Building the Business Case
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
By Design: Reduce Risk and Improve Compliance with a Layered Software Architecture
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
CAPA Report Template for the Medical Device Industry
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
CE Mark Technical Documentation: Changes, Application, and Notified Body Expectations under MDR
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
CEO Roundtable: Leading Your MedTech Company in 2023 and Beyond
CEO Roundtable: Leading Your MedTech Company in 2023 and Beyond
0 hr 37 min
Advance Exclusive Webinar
Challenges with Applying Risk Management Throughout the Manufacturing Process
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: 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
Concept to Commercialization Panel
Concept to Commercialization Panel
0 hr 41 min
Advance Exclusive Webinar
Customer Feedback and Complaint Form Template
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
Design Controls, Development, and Risk for SaMD
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
Developing a New Clinically Relevant ICU Ventilator Fast
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
Economic Operators: Implementation Challenges and Opportunities
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
Effective Post-market Surveillance in the EU under MDR
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
Essentials of Software as a Medical Device
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
Evaluating need for Biocompatibility Testing & Mitigating Risks when Changing your Medical Device
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.
Limited Availability
Risk Management Change Management Initial QMS Procedures Product Development QMS Refinement & Regulatory Submissions Advance Exclusive Webinar
FDA 510(k) Overview
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
Fireside Chat with a MedTech Living Legend
Fireside Chat with a MedTech Living Legend
Limited Availability
1 hr 2 min
Advance Exclusive Webinar
From Concept to Commercialization: Introduction to Medical Device Development
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
From Self-Declaration to Certification: Proving Performance Under IVDR
From Self-Declaration to Certification: Proving Performance Under IVDR
Learn best practices around proving performance under the new IVDR requirements.
Limited Availability
0 hr 54 min
Product Development QMS Refinement & Regulatory Submissions Advance Exclusive Webinar
Future of Quality Panel
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
How and When to Conduct your First Hazard Analysis
How and When to Conduct your First Hazard Analysis
A session by Sarah Nixon, Quality Engineer with Rook Quality Systems
Limited Availability
0 hr 45 min
Ideation & Prototyping Product Development Advance Exclusive Webinar
How to Apply Risk Management Throughout the Product Lifecycle of your Medical Device
How to Apply Risk Management Throughout the Product Lifecycle of your Medical Device
A session by Mike Baca, President at White Rook Consulting
Limited Availability
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
How to Create Medical Device Labels per EU MDR
A session by Monir El Azzouzi, Founder and CEO at Easy Medical Device
Limited Availability
0 hr 55 min
Initial QMS Procedures Product Development QMS Refinement & Regulatory Submissions Product Launch Advance Exclusive Webinar
How to Efficiently Document your Design Transfer to Ace your Audit and Product Launch
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
How to Integrate Risk Management Throughout the Lifecycle of a Medical Device
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
How to Meet Cybersecurity Requirements of EU MDR & IVDR
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.
Limited Availability
0 hr 54 min
Initial QMS Procedures Product Development QMS Refinement & Regulatory Submissions Advance Exclusive Webinar
How to Predict Medical Device Recalls using Publicly Available Data
How to Predict Medical Device Recalls using Publicly Available Data
A session by Mohammed (Bilash) Hossain and John Lorenc of Reed Tech
Limited Availability
0 hr 45 min
QMS Refinement & Regulatory Submissions Post-Market Surveillance Advance Exclusive Webinar
Implementation of Risk Management Board for New Product Introduction and PMS
Implementation of Risk Management Board for New Product Introduction and PMS
Limited Availability
0 hr 56 min
Risk Management Advance Exclusive Webinar
Implementing and Maintaining Changes to SaMD Under MDR
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.
Limited Availability
0 hr 51 min
Product Development QMS Refinement & Regulatory Submissions Advance Exclusive Webinar
Internal Audit Checklist
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
Is your Use-Related Risk Analysis Half Empty or Half Full?
Is your Use-Related Risk Analysis Half Empty or Half Full?
Limited Availability
0 hr 26 min
Risk Management Advance Exclusive Webinar
Managing Risks Along an IVD-Analyzer's Life-Cycle
Managing Risks Along an IVD-Analyzer's Life-Cycle
A session by Christopher Schar, Senior Consultant with QUNIQUE
Limited Availability
0 hr 44 min
Advance Exclusive Webinar
MedTech Cybersecurity Panel
MedTech Cybersecurity Panel
Limited Availability
0 hr 40 min
cybersecurity Advance Exclusive Webinar
Nonconformance Report Template
Nonconformance Report Template
Use this template to document nonconformance in your QMS.
Limited Availability
Audit QMS Template Product Launch Post-Market Surveillance Advance Exclusive
Overview of CAPA
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
Overview of Complaints
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
Overview of Nonconformance
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
Perfecting the Pitch: Fundraising Roundtable of Early Stage Investors
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
Planning your Cloud Connectivity Strategy to Reduce Cybersecurity and Privacy Risk
Planning your Cloud Connectivity Strategy to Reduce Cybersecurity and Privacy Risk
A session by Abbas Dhilawala, CTO at Galen Data
Limited Availability
0 hr 45 min
cybersecurity Product Development QMS Refinement & Regulatory Submissions Advance Exclusive Webinar
Pre-Market vs. Post Market Risk: What are the similarities and differences?
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
Protecting your Data from Risk: To, From, and In the Cloud
Protecting your Data from Risk: To, From, and In the Cloud
A session by Chris DuPont, CEO at Galen Data
Limited Availability
0 hr 45 min
Ideation & Prototyping Product Development QMS Refinement & Regulatory Submissions Product Launch Post-Market Surveillance Advance Exclusive Webinar
Quality Spotlight: Trials & Triumphs of Complaint Handling
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
Regulatory Pathways Round Table
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
Remote audits
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
Risk Management from a Regulatory and Product Development Perspective
Risk Management from a Regulatory and Product Development Perspective
Another favorite podcast episode with our frequent guest Mike Drues, Ph.D.
Limited Availability
Risk Management Regulatory Management Product Development QMS Refinement & Regulatory Submissions Advance Exclusive Podcast
Risk Management Plan Template
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
Significant Risk vs. Nonsignificant Risk Devices - What's the Difference?
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.
Limited Availability
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
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
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 Art of Defining Design Inputs and Design Outputs
The Art of Defining Design Inputs and Design Outputs
The art of defining design inputs & design outputs for FDA compliance by medical device manufacturers.
Limited Availability
Design Controls QMS Product Development Advance Exclusive eBook
The Basics of Bill of Materials (BOMs) for MedTech
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
The Basics of Cybersecurity for Medical Device Manufacturers
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
The Beginners Guide to Design Verification and Design Validation for Medical Devices
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.
Limited Availability
Design Controls Product Development QMS Refinement & Regulatory Submissions Advance Exclusive eBook
The Definitive Guide to Change Management for Medical Devices
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.
Limited Availability
Document Management Change Management Initial QMS Procedures Product Launch Post-Market Surveillance Advance Exclusive eBook
The Definitive Guide to Responding to FDA 483 and Warning Letters
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.
Limited Availability
Initial QMS Procedures QMS Refinement & Regulatory Submissions Post-Market Surveillance Advance Exclusive eBook
The Future of Health and Medicine: Where Can Technology Take Us?
The Future of Health and Medicine: Where Can Technology Take Us?
Limited Availability
0 hr 47 min
Advance Exclusive Webinar
The Importance of Design Controls
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
The Ins and Outs of Supplier Management
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
The Journey Continues: What to Know for US FDA Class I and other Global Regulator UDI Requirements
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
The Risk Management Process and ISO 14971
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
The Ultimate Guide to CAPA
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.
Limited Availability
CAPA QMS Product Launch Post-Market Surveillance Advance Exclusive eBook
The Ultimate Guide to Design Controls for Medical Device Companies
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.
Limited Availability
Design Controls ISO 13485 Ideation & Prototyping Product Development Advance Exclusive eBook
The Ultimate Guide to Document Control for Medical Device Companies
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.
Limited Availability
Document Management Change Management ISO 13485 QMS Initial QMS Procedures Post-Market Surveillance Advance Exclusive eBook
The Ultimate Guide to ISO 13485:2016 Quality Management System for Medical Devices
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.
Limited Availability
ISO 13485 QMS Initial QMS Procedures Post-Market Surveillance Advance Exclusive eBook
The Ultimate Guide to Training Management for Medical Device Companies
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.
Limited Availability
Training ISO 13485 QMS Initial QMS Procedures Post-Market Surveillance Advance Exclusive eBook
The Wait is Over: Assessing the Proposed Rule Aligning FDA's Medical Device Quality System Regulation with ISO 13485:2016
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
The Who, What, and When of IVDR Enforcement
The Who, What, and When of IVDR Enforcement
A session by Joanne Lebrun, Vice President at MDC Associates Inc.
Limited Availability
0 hr 52 min
EU MDR Post-Market Surveillance Advance Exclusive Webinar
This is not your grandmother's validated state!
This is not your grandmother's validated state!
Limited Availability
0 hr 38 min
Design Controls Quality Management Product Development Advance Exclusive Webinar
Tips for Working with Contract Manufacturing
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
Ultimate Guide to 21 CFR Part 820 - FDA's Quality System Regulation for Medical Devices
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..
Limited Availability
Risk Management Document Management CAPA Design Controls QMS Initial QMS Procedures Post-Market Surveillance Advance Exclusive eBook
Ultimate guide to Agile Design and Development for Medical Devices
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.
Limited Availability
Risk Management Document Management Design Controls Change Management Ideation & Prototyping Product Development Advance Exclusive eBook
Understanding the Medical Device Single Audit Program (MDSAP): Pros, Cons, and How to Prepare
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
Using the Bucket Method for Medical Device Risk Management
Using the Bucket Method for Medical Device Risk Management
Mike Drues joins the podcast again to talk some more about Risk Management
Limited Availability
Risk Management Initial QMS Procedures Product Development QMS Refinement & Regulatory Submissions Product Launch Advance Exclusive Podcast
What is a Medical Device?
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
What is the Best Way to Structure a Risk Management File
What is the Best Way to Structure a Risk Management File
A session by Carolyn Guthrie, Director QA/RA at Kapstone Medical
Limited Availability
0 hr 48 min
Initial QMS Procedures Product Development Advance Exclusive Webinar
A Resource Pack for the MedTech Entrepreneur
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
The Power of 3D-Printed Medical Devices
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
Raising Capital for Medical Device Startups
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
Mindset Tools for High Performance Teams
Mindset Tools for High Performance Teams
Limited Availability
0 hr 31 min
Advance Exclusive Webinar
Entrepreneur's Guide Welcome Course
Entrepreneur's Guide Welcome Course
Limited Availability
Raising Capital for Medical Device Startups
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
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
Mindset Tools for High Performance Teams
Limited Availability
0 hr 31 min
Advance Exclusive Webinar
CEO Roundtable: Leading Your MedTech Company in 2023 and Beyond
CEO Roundtable: Leading Your MedTech Company in 2023 and Beyond
0 hr 37 min
Advance Exclusive Webinar
Concept to Commercialization Panel
Concept to Commercialization Panel
0 hr 41 min
Advance Exclusive Webinar
Building Companies and Careers: Your Brand
Building Companies and Careers: Your Brand
Currently Unavailable
0 hr 41 min
Advance Exclusive Webinar
From Concept to Commercialization: Introduction to Medical Device Development
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
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
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
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
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
Entrepreneur's Guide Welcome Course
Limited Availability
Developing a New Clinically Relevant ICU Ventilator Fast
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
The Power of 3D-Printed Medical Devices
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
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
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
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
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

This website stores cookies on your computer. These cookies are used to collect information about how you interact with our website and allow us to remember you. We use this information in order to improve and customize your browsing experience and for analytics and metrics about our visitors both on this website and other media. To find out more about the cookies we use, see our Privacy Policy and other Terms and Conditions at https://www.greenlight.guru/legal-info.

×
Greenlight Guru Academy specializes in providing education and training resources for medical device professionals.
Education
Content Memberships Certificates
Resources
Templates & Checklists Ebooks & Guides Global Medical Device Podcast GG Medical Device Blog Glossary Partner Directory
Events
Calendar Webinars True Quality Roadshow
Training
GG QMS Partners Gators
Help
Contact Support Advisory Services Guru Edge Sales