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 N95 Respirators, Surgical Masks, and Face Masks Nabil Khan Devin Hubbard FastTraCS FastTraCSClinical Advisory Group GuideWire Podcast on Twitter GuideWire Podcast   Quotes/Tweets: “Up until that point, we were growing fast and furious in a good way.” “We now have been able to open up our talent pools to markets that might have not been accessible to us.” “Medical device - it’s the long play. It’s not the short-term thing. There will be a need for my product, my technology.” “There were a lot of positives that have come through the pandemic. I saw the collaboration, the sharing, the openness.”