In this episode of GuideWire, Devin Hubbard with FastTraCS talks to Jon Speer, founder of Greenlight Guru and host of the Global Medical Device Podcast.
Jon discusses the origins of his company, electronic quality management software (QMS), and entrepreneurship experiences in the startup world.
Today’s Topics Include:
Links and Resources:
Greenlight Guru Medical Device Blog
Greenlight Guru YouTube Channel
Greenlight Guru - The Ultimate Guide to Design Controls
Greenlight Guru - Definitive Guide to ISO 14971:2019 Risk Management for Medical Devices
U.S. Food and Drug Administration (FDA)
FDA - Guidance Document on Design Controls
FDA - Emergency Use Authorization (EUA)
FastTraCS Clinical Advisory Group
Quotes/Tweets:
“Prior to Greenlight, there was no software solution designed specifically for the medical device industry.”
“My approach to a quality system is really about scaling it and evolving it as you go.”
“A quality system is really describing how we do business.”
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