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

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Text version: https://stenobird.com/podcast/let-s-talk-risk-podcast-6693844/ltr-136-adam-isaacs-rae-on-what-qmsr-really-changes-and-what-it-doesn-t.md
Podcast: [Let's Talk Risk! Podcast](https://stenobird.com/podcast/let-s-talk-risk-podcast-6693844)
Published: 2025-12-12T13:00:00+00:00
Episode link: https://naveenagarwalphd.substack.com/p/ltr-136-adam-isaacs-rae-on-what-qmsr-really-changes-and-what-it-doesnt
Audio file: https://api.substack.com/feed/podcast/179167457/3eca597a458cb535dd40422034bc3447.mp3
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Duration seconds: 1647

## Resource

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 will continue to operate exactly as before such as design control expectations, CAPA rigor, complaint handling scrutiny, and the agency’s ability to dig deeper under the broader ISO 13485 framework. Across thirty minutes, Naveen and Adam explore how QMSR will shift the conversation from timeliness to effectiveness , from dashboards to real risk thinking, and from procedural compliance to deliberate regulatory strategy in complex multi-market environments. Listen to the full 30-minute podcast or jump to a section of interest listed below. Chapters 00:00 Introduction and welcome 00:53 The story behind “The Other Consultants” 02:22 Why QMSR prep must go beyond gap assessments 03:12 What QMSR won’t change and why it matters 04:59 Design control complexity under QMSR 08:00 FDA’s deeper reach into complaints and risk 13:41 CAPA becomes CA + PA and effectiveness takes center stage 23:07 Key takeaways and closing remarks If you enjoyed this podcast, consider subscribing to the Let’s Talk Risk! newsletter . Suggested links: LTR: 90-Day Action Plan to Review QMSR Readiness . LTR: Beyond Compliance - Building Good Practices Under QMSR . ACHIEVE Workshop: Using ChatGPT to Analyze Recalls and Adv…

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