# LTR 137: Priya Setty on QMSR, Risk-Based Assurance, and Building a Future-Ready RA Career

Page: https://stenobird.com/podcast/let-s-talk-risk-podcast-6693844/ltr-137-priya-setty-on-qmsr-risk-based-assurance-and-building-a-future-ready-ra-career
Text version: https://stenobird.com/podcast/let-s-talk-risk-podcast-6693844/ltr-137-priya-setty-on-qmsr-risk-based-assurance-and-building-a-future-ready-ra-career.md
Podcast: [Let's Talk Risk! Podcast](https://stenobird.com/podcast/let-s-talk-risk-podcast-6693844)
Published: 2025-12-19T13:00:00+00:00
Episode link: https://naveenagarwalphd.substack.com/p/ltr-137-priya-setty-on-qmsr-risk-assurance-and-career-advice-for-qara
Audio file: https://api.substack.com/feed/podcast/181182223/04938ad64ce488870e983a7fb06de9c1.mp3
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Duration seconds: 1904

## Resource

Summary “FDA isn’t asking whether you followed the procedure. They are asking whether your system can assure consistent outcomes in the real world.” In this episode of the Let's Talk Risk Podcast , Priya Setty joins host Naveen Agarwal to unpack why QMSR represents more than a procedural update; it’s a mindset shift toward assurance, credibility, and risk-based decision making across the entire product lifecycle. Priya shares how the FDA’s alignment with ISO 13485 elevates expectations for design controls, risk integration, software assurance, and role-specific competence. Drawing on her clinical roots, global regulatory experience, and work in regulatory intelligence, Priya discusses how RA/QA professionals can prepare for future expectations through deeper understanding of risk, building strong feedback loops, developing competence beyond training, and embracing leadership roles that shape culture, not just documentation. Chapters 00:00 Why QMSR is a shift from compliance to assurance. 01:00 Priya’s unconventional journey from occupational therapy to regulatory affairs. 04:00 How FDA expects QMSR readiness to show up in pre-market submissions. 07:00 Compliance vs. assurance: Priya’s analogy for FDA’s mindset shift. 09:30 Software assurance, least burdensome validation, and risk-based thinking. 13:00 Why QMSR requires more than documentation—evidence of decision-making maturity. 17:00 The future of inspections: competence, culture, and systemic vulnerabilities. 22:00 Priya’s advice on preparing for QMSR and building a future-ready RA/QA career. Suggested links: * FDA: Draft Guidance - QMS Information for PMA Reviews . * LTR: Megan Kane on Leading QMSR Readiness in a Startup . * LTR: A 90-Day QMSR Readiness Action Plan for Leaders . Key Takeaways * QMSR represents a mi…

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