Season 2 - Episode 7: The Effects of COVID-19 on Regulatory Affairs GuideWire

In this episode of GuideWire, Devin Hubbard and Nabil Khan with FastTraCS talk to Jon Speer, founder of Greenlight Guru and host of the Global Medical Device Podcast.
 Jon discusses how the COVID-19 pandemic and shutdown affected the quality and regulatory affairs industry and specifically, Greenlight Guru as a company and quality management system (QMS).
 
Today’s Topics Include:

Greenlight Guru’s QMS: Needed now more than ever for to access documents, records
Rules Change: Why Greenlight Guru decided to allow remote work to continue growing
Greenlight Growth: Expected, forecasted, and planned for but faster because of COVID
Industry Impact: Companies struggled, shut down, or shifted development efforts
Clinical Trials/Investigations: COVID changed how these are being conducted
New Types of Med Device Companies: Naive about requirements and regulations
Positive Outcomes: In this together, so collaborate and share knowledge, feedback
Emergency Use Authorization (EUA): FDA’s criteria for risk tolerance and assessment
Side Effects: Longer lead times but faster standard practice to develop medical devices

 
Links and Resources:
Greenlight Guru
Greenlight Guru Podcasts
Greenlight Guru - Definitive Guide to ISO 14971:2019 Risk Management for Medical Devices
Greenlight Guru - ISO 13485: Ultimate Guide to the Quality Management System (QMS) for Medical Devices
Greenlight Guru - Ultimate Guide to 21 CFR Part 820
Greenlight Guru - The Ultimate Guide to Design Controls
FDA - Guidance Document on Design Controls
FDA - Emergency Use Authorization (EUA)
FDA - 510(k) Submission Process
FDA - Premarket Approval (PMA)
FDA - Case for Quality Initiative
National Institutes of Health (NIH) - Rapid Acceleration of Diagnostics (RADx Program)
ASTM International
F3502 Mask Standard
IEC 60601 Standard