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

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.”