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
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 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
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
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
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
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
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
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
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
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
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
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
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
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 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 "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
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
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
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
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
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
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
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
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 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 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 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.
Training
ISO 13485
QMS
Initial QMS Procedures
Post-Market Surveillance
Advance Exclusive
eBook
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
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
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
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
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.
Document Management
Change Management
Initial QMS Procedures
Product Launch
Post-Market Surveillance
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
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
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
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
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
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 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 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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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 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
🚨 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
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
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
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
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
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.
Training
ISO 13485
QMS
Initial QMS Procedures
Post-Market Surveillance
Advance Exclusive
eBook
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
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
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
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
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 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
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
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
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
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 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
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
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.
Document Management
Change Management
Initial QMS Procedures
Product Launch
Post-Market Surveillance
Advance Exclusive
eBook
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 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
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
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
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
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
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
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.
Document Management
Change Management
Initial QMS Procedures
Product Launch
Post-Market Surveillance
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
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
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
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 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 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
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
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
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
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
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 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.
Document Management
Change Management
Initial QMS Procedures
Product Launch
Post-Market Surveillance
Advance Exclusive
eBook
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