About this episode

The episode discusses how AI is transforming medical device regulation and quality practices while emphasizing the importance of human oversight.

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…

More episodes of Let's Talk Risk! with Dr. Naveen Agarwal

• LTR 161: AI Governance by Design · July 17, 2026 · 25 min
• Case Study: Why FDA Cybersecurity Expectations Are Really QMS Expectations · July 10, 2026 · 17 min
• LTR 160: IMSC26 Highlights - From Compliance to Proactive MedTech Safety · July 3, 2026 · 47 min
• Case Study: FDA’s New Expectation for Use-Related Risk in Medical Device Submissions · June 19, 2026 · 41 min

Explore listener stats, chart rankings, contacts and more on the Let's Talk Risk! with Dr. Naveen Agarwal podcast page.