Episode
LTR 163: FDA’s New Risk Lens Under QMSR
- Podcast
- Let's Talk Risk! Podcast
- Published
- Aug 14, 2026
- Duration seconds
- 1674
- Processing state
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Summary
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, increasingly, looking at the broader requirement to apply risk-based thinking across QMS processes under Clause 4.1.2. The conversation explores why companies already certified to ISO 13485 should not assume they are fully prepared for an FDA inspection, how FDA inspections may differ from notified-body audits, and why post-market information must feed back into risk management. Naveen and Allyson also discuss the legal and contractual implications of the transition, particularly the importance of reviewing quality agreements and clearly defining responsibilities when activities are outsourced. Finally, Allyson offers practical perspective on responding to FDA 483 observations and warning letters during a period when both regulators and industry are adapting to a new inspection framework. Listen to the full 25-minute podcast or jump to a section of interest listed below. Chapters 01:17 – Introduction and Allyson Mullen’s Regulatory and Legal Backgroun d 02:17 – FDA’s First QMSR Warning Letter and Its Risk Management Findings 03:46 – How FDA’s Language Around Risk Is Changing Under QMSR 05:10 – Risk Beyond Design Control: ISO 13485 Clause 4.1.2 07:42 – When FDA May Look Beyond Product Realization 12…