LTR 159: The Evolving Regulatory Landscape for AI in MedTech

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 or 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 around 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.Chapters00:00 – Introduction: AI in MedTech and why this conversation matters03:06 – Priya’s child development lens for understanding AI governance08:45 – EU AI Act vs MDR: horizontal regulation meets medical device rules11:15 – FDA’s lifecycle approach to AI-enabled medical devices23:17 – AI in post-market complaint triage and safety signal detection31:57 – PCCP for AI-enabled devices: opportunity, adoption, and business case36:05 – Career implications for QA/RA professionalsIf you enjoyed this podcast, consider subscribing to the Let’s Talk Risk! newsletter.Suggested links:* Navigating convergence and divergence between the EU MDR and EU AI Act* LTR: Case Study: Contrasting U.S. and EU Approaches to AI Regulation* LTR: LTR Risk Coach - AI-Powered Decision Support Tool.Key Takeaways* AI is not new, but the risk profile has changed.What has changed is broader access, greater autonomy, and higher consequence decisions.* AI governance is about keeping humans in charge.Organizations need clear boundaries, validation, monitoring, and human judgment at critical decision points.* The EU and FDA are approaching AI differently.The EU AI Act creates a broad governance overlay, while FDA continues to emphasize lifecycle control, context of use, and post-market performance.* AI can strengthen QA/RA work if used carefully.It can support complaint triage, audit preparation, regulatory intelligence, quality documentation, and change assessment.* Post-market monitoring becomes even more important with AI.AI systems should not be treated as “validated once and valid forever,” especially when models may drift or behave differently in real-world use.* PCCP is useful when the product roadmap is clear.It can support planned AI changes, but it is not a shortcut for uncertain models or poorly defined strategy.* QA/RA professionals need AI governance fluency.They do not need to become data scientists, but they should understand intended use, bias, drift, validation, and where human review is essential.KeywordsAI in medical devices, AI governance, AI-enabled medical devices, EU AI Act, FDA AI guidance, lifecycle management, post-market monitoring, PCCP, complaint triage, AI validation, change control, QA/RA professionalsAbout Priya SettyGeethapriya (Priya) Setty is a regulatory affairs strategist and systems builder with over eight years in global regulatory affairs and more than twenty years in healthcare. Starting her career as a pediatric occupational therapist, Priya brings a unique blend of clinical insight and policy expertise to the evolving world of medical technology. She leads regulatory intelligence and digital transformation initiatives at a global medical device company, specializing in global regulatory strategy, regulatory intelligence, and digital health/AI compliance for high-risk devices. Priya is adept at navigating complex regulations such as the EU AI Act and FDA guidance, ensuring compliance is embedded in every innovation.A certified PMP, RAC (Devices), and ISO 13485 lead auditor, Priya is known for demystifying complex regulations and building systems that keep teams ahead of industry changes. Guided by her mantra, “make a choice, and make it happen,” she is dedicated to leadership, mentorship, and simplifying healthcare through curiosity and purpose-driven action.About Attrayee ChakrabortyAttrayee Chakraborty is a quality and regulatory leader specializing in digital health and AI-enabled medical devices. At Analog Devices, she drives QMS development, risk management, and AI governance to meet global regulatory standards. Recognized as Quality Magazine’s 2025 “Rookie of the Year” and a 2025 RAPS Rising Star, Attrayee has delivered talks at major industry events including RAPS, MDM West, and ISPE. She also serves on working groups with IEEE, RAPS, and SQA, shaping the future of healthcare AI compliance. Passionate about empowering early-career professionals, she bridges the gap between regulatory rigor and real-world innovation.DisclaimerInformation and insights presented in this podcast are for educational purposes only. Views expressed by all speakers are their own and do not reflect those of their respective organizations.Parts of this article were created using AI-generated content, which was subsequently reviewed, edited, and fact-checked by the author to ensure accuracy and alignment with our standards. This is a public episode. If you'd like to discuss this with other subscribers or get access to bonus episodes, visit naveenagarwalphd.substack.com/subscribe