LTR 136: Adam Isaacs Rae on What QMSR Really Changes and What It Doesn't
Let's Talk Risk! Podcast
- Published
- December 12, 2025
- Duration
- 27:27
- Summary source
- description
- Last updated
- Apr 29, 2026
Discusses Summary“Under QMSR, FDA will still be FDA, but they’ll finally have broader authority to cite what t…
Summary
Summary“Under QMSR, FDA will still be FDA, but they’ll finally have broader authority to cite what they’ve always cared about.”In this Let’s Talk Risk! conversation, host Naveen Agarwal sits down with Adam Isaacs Rae to unpack one of the most misunderstood aspects of FDA’s new QMSR rule: the parts that aren’t changing.Adam brings a unique dual-lens perspe…
Show notes
Summary“Under QMSR, FDA will still be FDA, but they’ll finally have broader authority to cite what they’ve always cared about.”In this Let’s Talk Risk! conversation, host Naveen Agarwal sits down with Adam Isaacs Rae to unpack one of the most misunderstood aspects of FDA’s new QMSR rule: the parts that aren’t changing.Adam brings a unique dual-lens perspective as both a medical device consultant and a lead auditor for certification bodies. With trademark clarity and humor, he explains why focusi