Episode
LTR 159: The Evolving Regulatory Landscape for AI in MedTech
- Podcast
- Let's Talk Risk! Podcast
- Published
- Jun 26, 2026
- Duration seconds
- 2536
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Summary
Summary “Stop thinking of AI as replacing humans. Think about humans staying in charge while AI is placed in the loop” Artificial intelligence is no longer a future concept in MedTech. It is already inside medical devices, quality systems, regulatory workflows, post-market processes, and product development decisions. In this episode of the Let’s Talk Risk Podcast , host Naveen Agarwal sits down with Priya Setty and Atty Chakraborty for a wide-ranging discussion on how AI is changing medical device regulation and quality practice. Priya frames AI through a human lens: like a child growing into adulthood, AI needs supervision, boundaries, and responsible “parenting.” Atty builds on that by explaining how the conversation has shifted from “How do we regulate AI?” to more practical questions about testing, validation, acceptance criteria, context of use, and lifecycle control. The discussion covers the EU AI Act, FDA’s total product lifecycle approach, global regulatory trends, post-market complaint triage, AI in audits and quality operations, change control, PCCP, and the career implications for QA/RA professionals. A recurring theme is clear: AI can improve the quality, consistency, and timeliness of decisions, but only if humans remain in charge. Chapters 00:00 – Introduction: AI in MedTech and why this conversation matters 03:06 – Priya’s child development lens for understanding AI governance 08:45 – EU AI Act vs MDR: horizontal regulation meets medical device rules 11:15 – FDA’s lifecycle approach to AI-enabled medical devices 23:17 – AI in post-market complaint triage and safety signal detection 31:57 – PCCP for AI-enabled devices: opportunity, adoption, and business case 36:05 – Career implications for QA/RA professionals If you enjoyed this podcast, consider subsc…