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May 2022
46m 33s

Bringing Medical Devices into the Home

Greenlight Guru + Medical Device Entrepreneurs
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Aug 10
#468: SaMD Issues, Defects & Detection | Shawnnah Monterrey
Most discussions around medical device quality stop at commercial launch. Once a product ships, teams tend to celebrate and move on to the next development cycle. However, the real engineering work often begins the moment a device leaves the manufacturing floor. In this episode o ... Show More
44m 9s
Aug 3
#467: Combination Product Compliance: PMOA, 21 CFR Part 4 & QMS Alignment
Navigating the regulatory landscape for combination products requires understanding how primary modes of action (PMOA) dictate oversight pathways. In this episode, host Etienne Nichols sits down with Jim Fentress, Director of Regulatory Affairs at Galero (a Santa Group company), ... Show More
35m 54s
Jul 27
#466: Leaving the Ivory Tower - How Notified Body Engagement Unlocks Startup Growth
Many early-stage medical device founders face a major dilemma: how do you prove regulatory maturity to investors and partners before you actually hold a final CE mark or FDA approval? Waiting until the end of a long development cycle creates significant commercial risk. By treati ... Show More
31m 43s
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