Let's Talk Risk! with Dr. Naveen Agarwal

Casual and informal conversations about practical aspects of medical device risk management.

Every Friday, Dr. Naveen Agarwal leads a Let's Talk Risk! conversation with industry colleagues to discuss practical challenges and share best practices in risk management. In the highly regulated world of medical devices, most practitioners struggle with the "how" of risk management. Regulatory requirements are complex, confusing and ever changing. Establishing an effective risk management process that satisfies the scrutiny of regulators and auditors without creating barriers to innovation is a significant challenge in the industry. Dr. Agarwal believes that no single "expert" has all the answers, and it is only when we connect, share and learn from each other that we all become better. Let us keep learning together! naveenagarwalphd.substack.com

  1. LTR 143: Jennifer Mascioli-Tudor on Leading Proactive Quality in the QMSR Era

    6D AGO

    LTR 143: Jennifer Mascioli-Tudor on Leading Proactive Quality in the QMSR Era

    Summary “Management review is no longer a check-the-box exercise. It’s the most powerful lever leaders have to drive proactive quality.” In this episode of the Let’s Talk Risk Podcast, Naveen Agarwal sits down with Jennifer Mascioli-Tudor, an experienced Quality and Regulatory leader, to unpack what QMSR readiness really means in practice. Jennifer shares what she’s seeing across the industry, from companies that are fully prepared to those that haven’t started, and explains why being ISO 13485 certified is not enough. The conversation dives deep into FDA inspection behavior, closed-loop risk management, management review as a leadership tool (not a formality), and the very real consequences of reactive quality systems. This episode is a must-listen for quality, regulatory, and executive leaders who want to move beyond compliance and build proactive, inspection-ready organizations. Chapters 00:00 Welcome and Introduction02:20 ISO 13485 vs FDA inspections: where assumptions break down03:40 Closed-loop risk management across the total product lifecycle05:40 How FDA uses complaints, CAPA, and trends to escalate inspections09:35 Leadership mindset shift: from reactive fixes to proactive quality11:35 Management review as a strategic decision-making forum20:25 Inspection readiness as culture, practice, and people, not paperwork If you enjoyed this podcast, consider subscribing to the Let’s Talk Risk! newsletter. Suggested links: * LTR: QMSR Readiness, Risk-Based Assurance and FDA Expectations. * LTR: 90-Day QMSR Readiness Action Pan for Leaders. * LTR: FDA Readiness for QMSR. Key Takeaways * Don’t wait for FDA to expose your gaps, identify and document them yourself * Treat QMSR as a strategic initiative, not a quality department project * Use management review to drive real discussion, decisions, and accountability * Focus on the critical few metrics, not dozens of unprioritized indicators * Train SMEs and cross-functional leaders to speak confidently about risk * Practice inspection scenarios before FDA shows up, not during the inspection Keywords QMSR, FDA inspection readiness, closed-loop risk management, ISO 13485, management review, risk-based decision making, proactive quality, trend escalation, cross-functional accountability, total product lifecycle About Jennifer Mascioli-Tudor Jennifer Mascioli-Tudor is currently the Founder and Principal Consultant at JMT Compliance Consulting offering consultant services to MedTech organizations in business, regulatory and quality management strategy. She is also an instructor at UC San Diego where she teaches regulatory fundamentals and design controls. Her industry experience includes leadership roles at J&J, Boston Scientific, Medtronic, and GE Healthcare. She holds a BSc from Eastern Michigan University, an MBA in Global Management, and is an ASQ Certified Quality Auditor. Disclaimer Information and insights presented in this podcast are for educational purposes only. Views expressed by all speakers are their own and do not reflect those of their respective organizations. Parts of this article were created using AI-generated content, which was subsequently reviewed, edited, and fact-checked by the author to ensure accuracy and alignment with our standards. This is a public episode. If you'd like to discuss this with other subscribers or get access to bonus episodes, visit naveenagarwalphd.substack.com/subscribe

    31 min
  2. LTR 142: Florian Tolkmitt on Clinical Evaluation, Risk, and the New ISO Draft Standard

    FEB 6

    LTR 142: Florian Tolkmitt on Clinical Evaluation, Risk, and the New ISO Draft Standard

    Summary “For years, clinical evaluations were mostly a story. What was missing were clearly defined outcome parameters, something measurable that connects the state of the art to benefit–risk conclusions.” In this Let’s Talk Risk! conversation, host Naveen Agarwal welcomes back Florian Tolkmitt, Managing Director of Pro-Liance Global Solutions, for a timely and highly practical discussion on clinical evaluation for medical devices. The conversation centers on the newly released draft ISO standard for clinical evaluation (ISO/DIS 18969), why it was developed, and what problem it is trying to solve. Florian shares first-hand insight from his role in the ISO working group, highlighting common industry misunderstandings, especially around outcome parameters, state of the art, and the linkage between clinical evaluation and ISO 14971 risk management. Together, Naveen and Florian unpack new terminology such as clinical risk, clinical outcome parameters, and available knowledge, clarifying how these concepts are meant to sharpen focus on patient-relevant benefit–risk decisions without overloading clinical evaluation with non-clinical risk data. The episode closes with practical reflections on how manufacturers, especially those struggling with EU MDR expectations, can use this process standard to strengthen their clinical evaluation approach. Listen to the full 30-minute podcast or jump to a section of interest listed below. Chapters 00:00 Welcome and introduction to the topic of clinical evaluation 01:25 What companies still get wrong about clinical evaluation 03:10 Overview of the new ISO/DIS 18969 draft standard 05:30 Why the standard is process-focused, not regulatory 06:20 ISO 14971 as a normative reference and the idea of “clinical risk” 10:20 State of the art vs. “available knowledge” 17:40 Clinical outcome parameters and measurable benefit–risk 25:00 Why this standard matters and who will benefit most If you enjoyed this podcast, consider subscribing to the Let’s Talk Risk! newsletter. Suggested links: LTR: Clinical Evaluation Now More Important Than Ever Under EU-MDR. LTR: Smart Use of AI for Clinical Evaluation. LTR: Clinical Evaluation a Lifecycle Process Not a One Time Activity. Key Takeaways * Clinical evaluation is not a narrative exercise, it must be outcome-driven. * Not all risks belong in clinical evaluation; patient-relevant risks do. * Outcome parameters should be derived from state of the art, not after the fact. * The new ISO draft aims to harmonize global practice without reinventing regulations. * A strong clinical evaluation process improves both regulatory confidence and decision quality. Keywords Clinical Evaluation, ISO/DIS 18969, Risk Management, ISO 14971, EU MDR, Clinical Risk, Benefit–Risk Assessment, State of the Art, Post-Market Surveillance, Medical Device Regulation About Florian Tolkmitt Florian Tolkmitt is the founder and owner of PRO-LIANCE GLOBAL SOLUTIONS GmbH providing consulting services in all aspects of clinical evaluation, regulatory affairs, risk and quality management. He is an expert in clinical evaluation, post-market clinical follow up and post-market reporting compliance. As a co-founder and board member of RAPS Deutschland e.V., he is very active in the regulatory community sharing his expertise and mentoring industry colleagues. Let’s Talk Risk! with Dr. Naveen Agarwal is a bi-weekly live audio event on LinkedIn, where we talk about risk management related topics in a casual, informal way. Join us at 11:00 am EST every Friday on LinkedIn. Disclaimer Information and insights presented in this podcast are for educational purposes only, and not as legal advice. Views expressed by all speakers are their own and do not reflect those of their respective organizations. Parts of this article were created using AI-generated content, which was subsequently reviewed, edited, and fact-checked by the author to ensure accuracy and alignment with our standards. This is a public episode. If you'd like to discuss this with other subscribers or get access to bonus episodes, visit naveenagarwalphd.substack.com/subscribe

    28 min
  3. LTR 141: Ashkon Rasooli on Applying an Agile Mindset to Risk-Based Quality Systems Under QMSR

    JAN 30

    LTR 141: Ashkon Rasooli on Applying an Agile Mindset to Risk-Based Quality Systems Under QMSR

    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 Leaders. * LTR: FDA Readiness for QMSR. Key Takeaways * Software risk is deterministic, not statistical: bugs fail 100% of the time once triggered. * Chasing “bug-free” software can delay safe, effective products and deny patients timely access. * Agile and quality are not opposites, but they must be reconciled through risk-based discipline, not speed alone. * Under QMSR, risk expands beyond safety to include cybersecurity, data integrity, and system reliability. * FDA inspections may increasingly link observations directly to deficiencies in risk-based decision-making. * A mature QMS must be practiced, not just documented; procedures alone won’t demonstrate control. * QA/RA leaders must treat the QMS itself as a product with internal users and continuously improve it. * Future quality leaders need enough technical fluency to engage engineering as partners, not adversaries. Keywords QMSR, FDA readiness, ISO 13485, MDSAP, FDA inspections, quality system regulation, risk-based quality, CAPA, post-market surveillance, QA/RA leadership About Ashkon Rasooli Ashkon Rasooli, is a medical device Quality Management Systems strategist specializing in SaMD, SiMD, and AI/ML-enabled technologies. He brings over a decade of experience across engineering, product management, regulatory, and quality roles, spanning large MedTech firms, big-tech environments, and VC-backed startups. Ashkon is the founder of EnGenius Solutions and is known for his pragmatic, “non-BS” approach to building quality systems that protect patients without stalling innovation. Disclaimer Information and insights presented in this podcast are for educational purposes only. Views expressed by all speakers are their own and do not reflect those of their respective organizations. Parts of this article were created using AI-generated content, which was subsequently reviewed, edited, and fact-checked by the author to ensure accuracy and alignment with our standards. Let's Talk Risk! is a reader-supported publication. To receive new posts and support my work, consider becoming a free or paid subscriber. This is a public episode. If you'd like to discuss this with other subscribers or get access to bonus episodes, visit naveenagarwalphd.substack.com/subscribe

    28 min
  4. LTR 140: Pujitha Gourabathini on Connecting Risk Management and Design Controls

    JAN 23

    LTR 140: Pujitha Gourabathini on Connecting Risk Management and Design Controls

    Summary “Risk management should not be a compliance checkbox. It must actively govern design decisions and feedback loops across the product lifecycle.” In this Let’s Talk Risk! conversation, host Naveen Agarwal sits down with Pujitha Gourabathini, Quality Assurance and Risk Management leader at Becton Dickinson, to explore one of the most persistent challenges in MedTech: effectively integrating risk management with design controls. Pujitha shares practical, experience-based insights on why risk files often become disconnected from design inputs, verification strategies, and sustaining engineering changes. Drawing on real-world examples, she explains how “like-for-like” assumptions, tight timelines, and limited cross-functional engagement can quietly erode patient safety if risk is not continuously reassessed. The conversation goes beyond procedures to focus on culture, highlighting the importance of collaboration, early engagement, and continuous improvement to ensure risk truly governs design decisions. As QMSR approaches, this episode offers timely guidance for QA/RA and engineering leaders looking to move from checkbox compliance to lifecycle risk assurance. Listen to the full 30-minute podcast or jump to a section of interest listed below. Chapters 00:00 Welcome and introduction01:00 Pujitha’s path into quality and risk management03:40 Where risk and design controls disconnect in practice05:20 Sustaining engineering: the most overlooked risk blind spot06:40 “Like-for-like” changes and dangerous hidden assumptions09:00 Proactive risk reassessment through continuous improvement11:10 Organizational barriers: timelines, awareness, and ownership25:05 Closing takeaways: culture, collaboration, and QMSR readiness If you enjoyed this podcast, consider subscribing to the Let’s Talk Risk! newsletter. Suggested links: LTR: Managing Post-Market Design Changes. LTR: Building Safety by Design. LTR: Beyond Compliance - Building Good Practices Under QMSR. Key Takeaways * Risk management must actively inform design inputs, outputs, and verification, not exist as a standalone file * Sample sizes and verification strategies should be scaled to patient impact, not convenience * Sustaining engineering changes often carry hidden risk and deserve the same rigor as new product development * “Like-for-like” component changes can invalidate prior risk analyses if assumptions go unchallenged * Continuous improvement programs work best when risk awareness extends beyond Quality into engineering and project management * Early collaboration reduces rework, delays, and late-stage risk discoveries * QMSR raises expectations for closed-loop feedback between design, risk, and post-market data Keywords Risk management, design controls, QMSR, sustaining engineering, ISO 14971, patient safety, verification strategy, continuous improvement, safety culture, lifecycle risk About Pujitha Gourabathini Pujitha Gourabathini is a Quality Assurance and Risk Management leader in the medical device industry with deep expertise in lifecycle risk integration, design controls, and post-market safety. She currently serves as a Quality Assurance Manager focused on risk management, where she leads cross-functional efforts to embed patient safety into both new product development and sustaining engineering activities. With hands-on experience across ISO 14971, FDA QSR/QMSR, EU MDR, and safety assurance practices, Pujitha is passionate about moving risk management beyond documentation toward practical, decision-driven application. She is an active contributor to industry discussions through writing, mentoring, and knowledge sharing—advocating for stronger safety culture, continuous improvement, and proactive risk ownership across organizations. Let’s Talk Risk! with Dr. Naveen Agarwal is a bi-weekly live audio event on LinkedIn, where we talk about risk management related topics in a casual, informal way. Join us at 11:00 am EST every Friday on LinkedIn. Disclaimer Information and insights presented in this podcast are for educational purposes only, and not as legal advice. Views expressed by all speakers are their own and do not reflect those of their respective organizations. Parts of this article were created using AI-generated content, which was subsequently reviewed, edited, and fact-checked by the author to ensure accuracy and alignment with our standards. This is a public episode. If you'd like to discuss this with other subscribers or get access to bonus episodes, visit naveenagarwalphd.substack.com/subscribe

    26 min
  5. LTR 139: Steve Silverman on FDA Readiness for QMSR

    JAN 16

    LTR 139: Steve Silverman on FDA Readiness for QMSR

    Summary “QMSR isn’t about regulatory obligation; it’s about managing business risk, protecting customers, and preserving market share.” In this episode of the Let's Talk Risk Podcast, host Naveen Agarwal is joined by Steve Silverman to explore a question that’s often left unspoken: Is the FDA ready for QMSR? Drawing on his experience as a former FDA leader and industry policy expert, Steve acknowledges that the current environment inside the agency is marked by workforce reductions, loss of institutional knowledge, and political disruption. But he also emphasizes that QMSR activation on February 2, 2026, is still very much on track. He cautions companies against “waiting it out” and explains why hoping for delays or informal grace periods is a risky strategy. The conversation dives into practical implications for manufacturers, including how FDA is preparing its inspectors, what the absence of updated QSIT guidance really means, why MDSAP certification is helpful but not sufficient, and how FDA is signaling stronger expectations around risk-based quality systems, especially in premarket reviews. The episode closes with clear advice for QA/RA leaders on how to frame QMSR readiness as a business risk and strategic opportunity, not just a regulatory exercise. Chapters 00:00 Why FDA readiness for QMSR matters as much as industry readiness 02:00 Inside FDA: disruption, workforce loss, and institutional impact 04:12 Will QMSR really go live in February 2026? 06:14 Lessons from MDSAP and parallels to QMSR rollout 10:40 How FDA prepares inspectors for a new regulatory framework 15:14 Why MDSAP certification is not a free pass under QMSR 19:14 What FDA inspections may look like in early 2026 27:58 How QA/RA leaders should explain QMSR to the C-suite Suggested links: * LTR: Communicating Effectively with Senior Executives. * LTR: 90-Day QMSR Readiness Action Pan for Leaders. * Steve’s Substack: What the FDA?. Key Takeaways * QMSR will activate on February 2, 2026, companies should not expect delays or extensions. * FDA has experienced significant disruption, including workforce reductions and loss of expertise, but core regulatory work continues. * Waiting to see how FDA “handles” QMSR is a high-risk strategy for manufacturers. * FDA inspectors are being trained internally to transition from QSR to QMSR, even without updated QSIT guidance. * MDSAP certification can ease the transition but does not replace FDA inspections or guarantee QMSR compliance. * FDA will continue enforcing recall and adverse event reporting requirements alongside QMSR. * Firms that demonstrate good-faith progress and a clear quality plan are likely to encounter a more collaborative FDA posture. * QMSR explicitly elevates risk as a lifecycle concept, spanning premarket, post-market, and business decision-making. * Leaders should assess their real exposure using post-market data and not assume compliance equals safety. * QA/RA leaders must translate QMSR work into business risk, market impact, and strategic value for executives. Keywords QMSR, FDA readiness, ISO 13485, MDSAP, FDA inspections, quality system regulation, risk-based quality, CAPA, post-market surveillance, QA/RA leadership About Steve Silverman Steve Silverman, is the President of The Silverman Group. Steve spent more than a decade at FDA in leadership positions across the Agency. He adds private-sector expertise from consulting and representing industry members. Steve develops strategies that satisfy regulators and promote business needs. He holds a Bachelor’s degree in English Literature, and a JD in Law. Disclaimer Information and insights presented in this podcast are for educational purposes only. Views expressed by all speakers are their own and do not reflect those of their respective organizations. Parts of this article were created using AI-generated content, which was subsequently reviewed, edited, and fact-checked by the author to ensure accuracy and alignment with our standards. Let's Talk Risk! is a reader-supported publication. To receive new posts and support my work, consider becoming a free or paid subscriber. This is a public episode. If you'd like to discuss this with other subscribers or get access to bonus episodes, visit naveenagarwalphd.substack.com/subscribe

    32 min
  6. LTR 138: Michelle Lott on QMSR Readiness, Risk-Based Assurance and FDA Expectations

    JAN 9

    LTR 138: Michelle Lott on QMSR Readiness, Risk-Based Assurance and FDA Expectations

    Summary “The industry is aware of QMSR, but they’re not moving. Many are still holding their breath, hoping something will change.” In this episode of the Let's Talk Risk Podcast, host Naveen Agarwal is joined by Michelle Lott for a deep and practical discussion on QMSR readiness as FDA’s February 2026 deadline rapidly approaches. Michelle shares a sobering view of where the medical device industry truly stands, highlighting a dangerous gap between awareness and action. The conversation explores how FDA is signaling its expectations well before inspections begin, particularly through new draft guidance for pre-market submissions. Together, Naveen and Michelle unpack what “risk-based approach” really means under QMSR, not just for design and development, but across supplier controls, CAPA, complaints, data analysis, and management review. They also examine one of the most consequential shifts under QMSR: FDA’s expanded authority to review management responsibility and system-level effectiveness. The episode closes on a forward-looking note, emphasizing the opportunity for QA/RA leaders to reposition themselves, not as compliance enforcers, but as strategic partners in prevention, assurance, and sustainable patient safety. Chapters 00:00 Why QMSR readiness matters now 01:00 Industry complacency and false hope for delays 05:00 FDA signals through pre-market guidance 09:00 Compliance vs. assurance: what FDA really wants 11:00 What “risk-based” means beyond ISO 14971 14:00 Where companies should prioritize immediately 17:00 Management review and executive accountability 26:00 The opportunity for QA/RA leadership under QMSR Suggested links: * LTR: Risk, CAPA and FDA Inspections under QMSR. * Lean RAQA: RAQA Services, Resources and Courses. * FDA: Voluntary Improvement Program (VIP). Key Takeaways * Many companies are aware of QMSR, but are still not acting with urgency. * ISO 13485 alignment significantly reduces compliance risk, but does not eliminate it. * FDA has already committed to inspecting against QMSR beginning February 3, 2026 and there is no grace period coming. * New PMA draft guidance signals FDA’s shift from compliance evidence to assurance of sustained safety and effectiveness. * “Risk-based approach” under QMSR applies across the entire QMS, not just ISO 14971 hazard analyses. * Management review is no longer protected territory; FDA can now assess how leadership identifies and responds to systemic risk. * The five chronic FDA pain points: CAPA, complaints, design controls, supplier controls, and nonconforming product, will matter even more under QMSR. * Strong QA/RA leaders can use QMSR as a platform to become prevention partners, not procedural gatekeepers. Keywords QMSR readiness, FDA QMSR, ISO 13485, risk-based approach, risk-based assurance, compliance vs assurance, FDA inspections, management review accountability, CAPA effectiveness, supplier controls, quality system maturity, QA/RA leadership About Michelle Lott Michelle Lott is the founder of Lean RAQA, where she provides fractional RA/QA leadership, audit prep, quality system design, and regulatory strategy for MedTech startups and small companies. With 20+ years of experience and an RAC certification, Michelle has helped hundreds of firms navigate FDA submissions and ISO compliance, bringing clarity and efficiency to even the most complex regulatory challenges. Disclaimer Information and insights presented in this podcast are for educational purposes only. Views expressed by all speakers are their own and do not reflect those of their respective organizations. Parts of this article were created using AI-generated content, which was subsequently reviewed, edited, and fact-checked by the author to ensure accuracy and alignment with our standards. Let's Talk Risk! is a reader-supported publication. To receive new posts and support my work, consider becoming a free or paid subscriber. This is a public episode. If you'd like to discuss this with other subscribers or get access to bonus episodes, visit naveenagarwalphd.substack.com/subscribe

    30 min
  7. LTR 137: Priya Setty on QMSR, Risk-Based Assurance, and Building a Future-Ready RA Career

    12/19/2025

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

    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 mindset shift: from proving compliance through procedures to demonstrating assurance through real-world performance and decision-making maturity. * FDA now expects integrated, lifecycle risk management, not isolated risk files; risk thinking must visibly connect design, verification/validation, manufacturing, and post-market actions. * Pre-market submissions will reflect QMSR readiness by showing how risk management drives design decisions, supplier oversight, and verification strategies. * Software assurance is now explicitly risk-based, requiring validation proportional to intended use and potential impact, reflecting the “least burdensome” approach. * Competence, not just training, will be scrutinized, and systemic gaps may escalate into management responsibility findings under QMSR. * Culture becomes a quality system indicator, especially how organizations make decisions, close feedback loops, and connect signals to design controls. * QMSR transition challenges differ by maturity: ISO 13485–certified companies refine and align; non-certified companies must build foundational structures. * RA/QA professionals must evolve into cross-functional leaders, shaping risk-informed culture, strengthening feedback systems, and developing deeper expertise in standards and regulatory philosophy. * Personal career growth principles - curiosity, networking, boldness, persistence - remain essential, especially as AI and digital technologies reshape regulatory practice. Keywords QMSR, Quality Management System Regulation, ISO 13485, Regulatory Affairs, Risk Management, Assurance Mindset, FDA Inspections, Software Assurance, Competence vs. Training, Regulatory Intelligence, Medical Devices, Digital Health. About Priya Setty Geethapriya (Priya) Setty is a regulatory affairs strategist and systems builder with over eight years in global regulatory affairs and more than twenty years in healthcare. Starting her career as a pediatric occupational therapist, Priya brings a unique blend of clinical insight and policy expertise to the evolving world of medical technology. She leads regulatory intelligence and digital transformation initiatives at a global medical device company, specializing in global regulatory strategy, regulatory intelligence, and digital health/AI compliance for high-risk devices. Priya is adept at navigating complex regulations such as the EU AI Act and FDA guidance, ensuring compliance is embedded in every innovation. A certified PMP, RAC (Devices), and ISO 13485 lead auditor, Priya is known for demystifying complex regulations and building systems that keep teams ahead of industry changes. Guided by her mantra, “make a choice, and make it happen,” she is dedicated to leadership, mentorship, and simplifying healthcare through curiosity and purpose-driven action. Disclaimer Information and insights presented in this podcast are for educational purposes only. Views expressed by all speakers are their own and do not reflect those of their respective organizations. Parts of this article were created using AI-generated content, which was subsequently reviewed, edited, and fact-checked by the author to ensure accuracy and alignment with our standards. Let's Talk Risk! is a reader-supported publication. To receive new posts and support my work, consider becoming a free or paid subscriber. This is a public episode. If you'd like to discuss this with other subscribers or get access to bonus episodes, visit naveenagarwalphd.substack.com/subscribe

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

    12/12/2025

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

    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 welcome00:53 The story behind “The Other Consultants”02:22 Why QMSR prep must go beyond gap assessments03:12 What QMSR won’t change and why it matters04:59 Design control complexity under QMSR08:00 FDA’s deeper reach into complaints and risk13:41 CAPA becomes CA + PA and effectiveness takes center stage23:07 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 Adverse Events. Key Takeaways * QMSR changes the requirements, not FDA’s inspection philosophy. The agency will still probe deeply and expect strong evidence of safety and effectiveness. * Design control complexity will increase. Especially for manufacturers managing the same device across the US, EU, and UK under a unified system. * Risk integration becomes unavoidable. Under ISO 13485, FDA can now cite weaknesses in risk-linked processes more explicitly. * Complaint handling scrutiny will intensify. Inspectors can now ask for “your highest-risk complaints”, and expect a defensible rationale. * CAPA becomes CA + PA. Terminology harmonizes with ISO, but FDA’s expectations for root cause depth and recurrence prevention remain unchanged. * Effectiveness will take center stage. FDA will look beyond timeliness KPIs and challenge the thinking behind effectiveness criteria. * Effectiveness must be defined up front. Not after the corrective actions are completed, a common failure mode in CAPA systems. * Recurrence and escapes remain FDA’s biggest red flags. QMSR simply gives them broader grounds to write findings. * Manufacturers must rethink regulatory strategy. Reliance sounds attractive, but differing market routes require clear separation and intentional planning. * The biggest risks come from what QMSR doesn’t change. These unchanged legacy expectations can “sting” manufacturers who assume harmonization means simplification. Keywords QMSR, ISO 13485, FDA inspections, design controls, CAPA, corrective action, preventive action, effectiveness criteria, complaint handling, risk-based quality, regulatory strategy, post-market surveillance About Adam Isaacs Rae Adam Isaacs Rae is a medical device quality and regulatory leader and Managing Director of The Other Consultants and The Other Auditors. With over a decade of experience across global medical device manufacturers, regulatory bodies, and certification audits, Adam brings a rare dual perspective as both consultant and lead auditor for ISO 13485. He specializes in pragmatic, risk-based compliance strategies that balance regulatory rigor with business realities, and is known for his clear, conversational approach to complex topics like QMSR, CAPA, and international market access. Let’s Talk Risk! with Dr. Naveen Agarwal is a bi-weekly live audio event on LinkedIn, where we talk about risk management related topics in a casual, informal way. Join us at 11:00 am EST every Friday on LinkedIn. Disclaimer Information and insights presented in this podcast are for educational purposes only, and not as legal advice. Views expressed by all speakers are their own and do not reflect those of their respective organizations. Parts of this article were created using AI-generated content, which was subsequently reviewed, edited, and fact-checked by the author to ensure accuracy and alignment with our standards. This is a public episode. If you'd like to discuss this with other subscribers or get access to bonus episodes, visit naveenagarwalphd.substack.com/subscribe

    27 min
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About

Every Friday, Dr. Naveen Agarwal leads a Let's Talk Risk! conversation with industry colleagues to discuss practical challenges and share best practices in risk management. In the highly regulated world of medical devices, most practitioners struggle with the "how" of risk management. Regulatory requirements are complex, confusing and ever changing. Establishing an effective risk management process that satisfies the scrutiny of regulators and auditors without creating barriers to innovation is a significant challenge in the industry. Dr. Agarwal believes that no single "expert" has all the answers, and it is only when we connect, share and learn from each other that we all become better. Let us keep learning together! naveenagarwalphd.substack.com

Information

  • Creator
    Casual and informal conversations about practical aspects of medical device risk management.
  • Years Active
    2023 - 2026
  • Episodes
    153
  • Rating
    Clean
  • Copyright
    © Naveen Agarwal, Ph.D.
  • Show Website
    Let's Talk Risk! with Dr. Naveen Agarwal

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