AI Is a Tool, Not a Replacement for MedTech Expertise with Mike Stuedemann, Co-Founder and Principal Consultant at agilityIRL
Move faster without losing focus: why medtech innovation must balance agility, regulation, and patient needs.
In this episode, Mike Stuedemann, Co-Founder and Principal Consultant at agilityIRL, discusses how medical device companies can use agile techniques to accelerate product development while maintaining FDA compliance. He explores the regulatory challenges surrounding AI-enabled devices, particularly as technologies continue to learn and evolve after launch. Mike also explains how AI can support quality and regulatory teams by identifying potential risks, flagging requirements for…
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