{"podcast":{"title":"Let's Talk Risk! Podcast","slug":"let-s-talk-risk-podcast-6693844","podcast_index_feed_id":6693844,"rss_url":"https://api.substack.com/feed/podcast/1477050.rss","website_url":"https://naveenagarwalphd.substack.com/podcast","image_url":"https://substackcdn.com/feed/podcast/1477050/ee2039dcd34796f25b1263b7e1659bef.jpg","author":"Where MedTech professionals gain clarity and confidence to navigate complex decisions.","episode_count":166,"summary":"Where MedTech professionals gain clarity and confidence to navigate complex risk, quality, and leadership challenges.","last_synced_at":null,"page_url":"https://stenobird.com/podcast/let-s-talk-risk-podcast-6693844"},"episode":{"title":"LTR 141: Ashkon Rasooli on Applying an Agile Mindset to Risk-Based Quality Systems Under QMSR","slug":"ltr-141-ashkon-rasooli-on-applying-an-agile-mindset-to-risk-based-quality-systems-under-qmsr","published_at":"2026-01-30T13:00:00+00:00","page_url":"https://stenobird.com/podcast/let-s-talk-risk-podcast-6693844/ltr-141-ashkon-rasooli-on-applying-an-agile-mindset-to-risk-based-quality-systems-under-qmsr","show_page_url":"https://stenobird.com/podcast/let-s-talk-risk-podcast-6693844","url":"https://naveenagarwalphd.substack.com/p/ltr-141-ashkon-rasooli-on-applying-agile-mindset-to-quality-systems-under-qmsr","audio_url":"https://api.substack.com/feed/podcast/185582762/0d7e1e8fbc5243b1afacb44c6e919302.mp3","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…","meta_description":"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…","key_points":[],"chapters":[],"topics":[],"duration_seconds":1674,"processing_state":"not_requested","actions":[{"name":"request_transcript","method":"POST","url":"https://stenobird.com/v1/public/podcasts/let-s-talk-risk-podcast-6693844/episodes/ltr-141-ashkon-rasooli-on-applying-an-agile-mindset-to-risk-based-quality-systems-under-qmsr/transcription-requests","description":"Idempotently request low-priority transcript generation for this episode."},{"name":"read_markdown","method":"GET","url":"https://stenobird.com/podcast/let-s-talk-risk-podcast-6693844/ltr-141-ashkon-rasooli-on-applying-an-agile-mindset-to-risk-based-quality-systems-under-qmsr.md","description":"Read the agent-friendly Markdown representation of this episode resource."}]}}