LTR 163: FDA’s New Risk Lens Under QMSR
Let's Talk Risk! Podcast
- Published
- August 14, 2026
- Duration
- 27:55
- Summary source
- description
- Last updated
- Aug 19, 2026
Discusses Summary“I don't think it's as easy to outsource risk as it used to be. Risk is pervasive now.”In thi…
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 de…
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Show notes
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, Allyso