Episode
LTR 141: Ashkon Rasooli on Applying an Agile Mindset to Risk-Based Quality Systems Under QMSR
- Podcast
- Let's Talk Risk! Podcast
- Published
- Jan 30, 2026
- Duration seconds
- 1674
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Summary
Summary “Delaying a product that is adequately safe and effective is itself a risk, one we rarely acknowledge in our quality systems.” In this episode of the Let's Talk Risk Podcast , host Naveen Agarwal speaks with Ashkon Rasooli, a seasoned SaMD and AI/ML quality strategist, about what QMSR readiness really means for software-heavy medical device organizations. Ashkon explains why traditional hardware-centric quality thinking breaks down in software environments, where failures are deterministic, complexity is effectively infinite, and rapid iteration is the norm. He challenges the industry’s fixation on “bug-free” software and over-proceduralized QMS, arguing instead for quality systems that emphasize risk-based decision-making, shared ownership, and real-world practice . The conversation explores how QMSR’s deeper integration of ISO 13485 and risk management will reshape inspections, elevate expectations around cybersecurity and supplier oversight, and require QA/RA leaders to rethink their role—from compliance enforcers to system designers and collaborators. Chapters 00:00 Welcome and introduction 01:00 Fundamental differences between software and hardware risk 04:50 Agile development vs. quality system control: where conflict arises 07:40 Why “move fast and break things” fails in medical devices 09:10 Bringing agility and ISO 13485 together through risk-based thinking 12:05 QMSR’s implications for SaMD, cybersecurity, and supplier management 16:20 Moving beyond procedures: practicing risk, not just documenting it 20:20 Treating the QMS as a product with internal customers 24:30 Delayed innovation as an overlooked form of patient risk Suggested links: * LTR: QMSR Readiness, Risk-Based Assurance and FDA Expectations . * LTR: 90-Day QMSR Readiness Action Pan for Lea…