LTR 136: Adam Isaacs Rae on What QMSR Really Changes and What It Doesn't

Let's Talk Risk! Podcast · Dec 12, 2025 · 27m

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 focusing only on “closing gaps” misses the real risk. The conversation dives into places where FDA…