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:
Links and Resources:
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)
N95 Respirators, Surgical Masks, and Face Masks
FastTraCSClinical Advisory Group
“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.”
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