LTR 163: FDA’s New Risk Lens Under QMSR

Podcast: Let's Talk Risk! Podcast · Where MedTech professionals gain clarity and confidence to navigate complex decisions.

Opublikowano: 2026-08-14

Summary “I don't think it's as easy to outsource risk as it used to be. Risk is pervasive now.” In this episode of the Let’s Talk Risk! conversation, host Naveen Agarwal speaks with Allyson Mullen, Director at Hyman, Phelps & McNamara, P.C., about what FDA’s early enforcement activity under the Quality Management System Regulation (QMSR) may tell medical device manufacturers about the agency’s evolving expectations. Using the first warning letter discussed in the episode as a starting point, Allyson examines how FDA is citing risk management under ISO 13485 Clause 7.1 and, increasing...