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Podcast: Beyond Clean Podcast
Episode: Shawn Flynn: Medical Device Instructions for Use - Episode 3
Description: This week on Beyond Clean we speak with Shawn Flynn, a Consultant, Entrepreneur, and Medical Device Inventor who is the founder and President of The Peritorum Group. Shawn gives listeners a look inside the process of gaining 510k approval and building a quality system that includes a risk analysis component. Dealing with various cycle times, the resulting bottleneck, and who to contact when dealing with smaller startup device companies is also covered. While there can be great pressure to cut corners in order to meet demand, Shawn encourages technicians and managers to have the backbone to say no and adv...