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