Let's Talk Risk! Podcast

Summary

“Test, test, test - and don’t accept the outcome unless you’re fairly confident in the level of uncertainty that remains.”

Companion diagnostics (CDx) are inherently high-consequence because they can directly shape treatment decisions. That reality drives a higher bar for clarity: intended use boundaries, evidence expectations, and tight specificity in what the test is claiming and for whom.

In this Let’s Talk Risk! conversation, host Naveen Agarwal sits down with Chris Daly to discuss how AI is transforming the MedTech landscape, including CDx, and how FDA’s expectations are evolving in this area. Chris emphasizes anchoring on the clinical question, using AI as a tool (not a vague strategy), and making uncertainty explicit: not “can we explain everything,” but “how much uncertainty is acceptable for this intended use?”

Listen to the full 30-minute podcast or jump to a section of interest listed below.

Chapters

00:00 2026 context: uncertainty is rising; fundamentals matter

05:00 CDx basics: why CDx is different (and higher-stakes)

07:05 AI/ML + diagnostics: define the question, bound the tool

09:40 Explainability vs uncertainty: “how much confidence is enough?”

14:10 The human factor: vigilance and better questions

18:10 FDA and CDx: what “evolving approach” may signal

21:30 Dataset boundaries, bias, and representativeness as safety issues

25:40 Closing: adapting to rapid AI rise through discipline + alignment

If you enjoyed this podcast, consider subscribing to the Let’s Talk Risk! newsletter.

Suggested links:

LTR: Three Pillars for Defining Your IVD Risk Management Strategy.

LTR: Responsible AI and Future of MedTech Safety.

FDA: Companion Diagnostics.

Key Takeaways

* CDx is high-stakes by design. If the test can steer therapy, FDA (and clinicians) will demand tighter specificity on intended use, population, and claims.

* The real compliance challenge is uncertainty, not buzzwords. Move the discussion from “can you explain it?” to “how confident are we, and what uncertainty are we accepting for this use?”

* Adjusting to AI’s rise means upgrading the team’s habits. Better questions, tougher validation, and active skepticism are the guardrails, especially when outputs can be wrong or misleading.

* Your training data defines your safety boundary. If the dataset doesn’t represent the real population/use context, we should not be surprised by bias and performance gaps in the real world.

* FDA’s CDx posture is evolving, but rigor isn’t going away. Reclassification signals pathway experimentation,

* AI readiness is cross-functional risk governance. The winners align science, quality, regulatory, and commercial goals around shared definitions, shared uncertainty, and shared decision logic.

Keywords

Companion diagnostics (CDx), AI/ML diagnostics, FDA CDx policy, reclassification, intended use, uncertainty, explainability, bias, lifecycle control, vigilance.

About Chris Daly

Chris Daly is a healthcare and life science executive and Principal at IronLine Consulting, where he helps emerging medical device manufacturers build regulatory and commercialization strategies for diagnostic products, especially companion diagnostics (CDx) and AI/ML-enabled solutions.

He has supported FDA submissions, including successful clearances in infectious disease and software-as-a-medical-device (SaMD), and works with teams on quality system development across device companies, diagnostic labs, and independent diagnostic testing facilities.

Before IronLine, Chris served as Chief Operating Officer of Total Child Health (CHADIS), a web-based screening and clinical management platform that uses pre-visit questionnaires to help clinicians streamline care and improve diagnosis and management of pediatric health, emotional, and behavioral concerns.

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 other 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.

Summary

“Look at how benefits and risks are allocated among different design options and pick a product architecture that minimizes risks and maximizes benefits.”

In this Let’s Talk Risk! conversation, Richard Matt shares a simple but uncomfortable observation: most organizations do risk “correctly” on paper, but too late to matter. By the time the DFMEA/PFMEA is polished, key architecture decisions are already locked, so risk management becomes cleanup, not guidance.

His most valuable takeaway is the shift upstream: start with the treatment plan, write down the expected benefits and plausible risks early, and iterate them as the design evolves. When benefits are made explicit, you stop treating risk as a single independent variable and start using benefit–risk as a practical decision engine for design tradeoffs.

Listen to the full 30-minute podcast or jump to a section of interest listed below.

Chapters

00:00 Welcome and Introduction

01:04 Risk focus in QMSR

04:50 Risk as an input to design

05:33 Why FMEA alone is not sufficient

10:33 Consider both benefits and risks early in design

20:43 Audience questions

24:30 Closing remarks

If you enjoyed this podcast, consider subscribing to the Let’s Talk Risk! newsletter.

Suggested links:

LTR: Allison Komiyama on Rethinking Benefit-Risk in MedTech.

LTR: Benefit-Risk Evaluation of an AI/ML Enabled Device.

LTR: An Ideal Medical Device.

Key Takeaways

* Use benefit–risk early, not as an afterthought. Start at the treatment-plan/concept phase so benefit and harm shape architecture decisions before they’re hard to change.

* Make “benefit” explicit and usable. If you only optimize against harm, you can unintentionally degrade clinical value; benefit must be part of the design tradeoff logic from day one.

* FMEA is necessary, but often too late to drive architecture. Treat it as confirmation and refinement—not the first time risk influences design.

* Replace ad hoc early risk with a lightweight upstream method. A simple evolving list of benefits, risks, and the design choices they drove can outperform a “perfect” late-stage file.

* QMSR will expose weak integration between risk and design controls. The compliance work is not the hard part—the hard part is showing risk actually shaped the design.

Keywords

QMSR, ISO 13485, ISO 14971, design controls, risk-based thinking, DFMEA/PFMEA limits, hazards & hazardous situations, benefit–risk, early design inputs, architecture decisions, process validation (OQ/PQ), iterative development.

About Richard Matt

Richard Matt is Principal Consultant at Aspen Medical Risk Consulting, with over 30 years of experience in product development, quality engineering, and risk management. He specializes in innovative methods for benefit–risk assessment, FMEA, and integrated product development, helping medical device companies strengthen compliance and improve patient safety.

He is also the inventor of a patented “risk algebra” approach that enables clear, defensible comparisons of benefit and risk, a breakthrough with wide implications for devices, biologics, and combination products.

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 other 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.

Summary

“A company can become world class the day the quality team decides.”

In this Let’s Talk Risk! conversation, host Naveen Agarwal engages with Ganesh Sabat, former former CEO of Sahajanand Medical Technologies (SMT) and now Founder & Managing Partner of MedArtha Capital about a simple but hard truth: global scale in MedTech is earned through quality execution, not marketing narratives.

Ganesh walks through SMT’s transformation from an innovative startup into a globally recognized cardiovascular device company, then zooms out to India’s broader MedTech ambition. We unpack what’s missing (talent depth, shared learning, true design ownership), what’s emerging (incubation + device parks + incentives), and why quality leaders are the real “make-or-break” force behind India’s credibility on the world stage.

Listen to the full 30-minute podcast or jump to a section of interest listed below.

Chapters

00:00 Welcome and Introduction

02:09 SMT story: from “innovative startup” to global scale

04:54 The turning point: why Ganesh bet on quality as the growth lever

06:13 What investors demanded: proof, discipline, and scalable systems

08:39 India ecosystem reality: pharma-quality mindset vs device-grade rigor

11:22 “Quality as a system”: building defect prevention into process + design

15:21 Building the ecosystem: why shared learning + capability depth matter

18:58 Challenges and opportunities for MedTech startup

21:02 Achieving global success not through low-cost but high quality

24:25 Closing remarks

If you enjoyed this podcast, consider subscribing to the Let’s Talk Risk! newsletter.

Suggested links:

LTR: What QA/RA Professionals Need to Know About MedTech in India.

LTR: Navigating the Regulatory Landscape for SaMD in India.

LTR: Atty Chakraborty on India’s Rising MedTech Sector.

Key Takeaways

* Quality isn’t a checkpoint at the end. It’s a design-and-system discipline built upstream.

* SMT’s scaling story is framed as “investing in quality,” then validating it through clinical proof and execution rigor.

* Customer trust and investor confidence converge on the same requirement: consistent, reliable quality (and safety) at global standards.

* India’s MedTech ecosystem is growing rapidly, but limited depth of specialized quality talent slows the curve.

* Moving from pharma-style quality to device-grade quality requires engineering capability, process ownership, and design mastery.

* Many early-stage companies need more than capital. They need experienced, operator-led “corridor finding” through regulatory + commercialization complexity.

* Device parks and incentives can accelerate manufacturing and scale, but credibility still hinges on execution discipline.

* Ganesh’s closing challenge is direct: quality teams hold the leverage to make companies—and countries—world class.

Keywords

Quality culture; design controls; engineering-led quality; global scale-up; cardiovascular devices; stents; clinical evidence; India MedTech; regulatory rigor; manufacturing excellence.

About Ganesh Sabat

Ganesh Sabat is is the Founder & Managing Partner of MedArtha Capital, an visionary investment platform backing MedTech, medical device, and digital healthcare companies emerging from India and scaling globally.

Previously, Ganesh spent ~15+ years as a senior executive, most recently as CEO of Sahajanand Medical Technologies (SMT), where he helped scale a highly regulated cardiovascular medical device business across innovation, manufacturing, quality, regulatory pathways, and international markets, building presence across 80+ countries and driving sustained growth.

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 other 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.

Summary

“You don’t want to be implementing QMSR while the FDA is waiting in the lobby.”

As the FDA transitions from the Quality System Regulation (QSR) to the new Quality Management System Regulation (QMSR), confusion persists across the MedTech industry. Is ISO 13485 certification enough? Does MDSAP cover everything? What exactly will FDA inspectors expect?

In this episode of the Let’s Talk Risk Podcast, host Naveen Agarwal sits down with Holly Cotter to talk about what this transition really means for manufacturers, especially startups and U.S.-only companies.

Holly brings a rare perspective: biomedical engineer, hands-on clinical experience, global regulatory consultant, and community builder. Together, we unpack not just regulatory changes — but the leadership opportunity QMSR presents for quality and regulatory professionals.

Chapters

00:00 Introduction and QMSR transition02:25 Explicit vs. implied changes under QMSR06:00 Risk beyond design validation: FDA’s broader lens09:30 Inspection uncertainty: Q-SIT, guidance gaps, and readiness11:35 MDSAP alignment: what it covers — and what it doesn’t14:00 The Quality Plan: your most practical readiness tool20:10 Dangerous assumptions about ISO 13485 certification25:40 indieMedTech: building community in MedTech

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

* ISO 13485 certification ≠ automatic QMSR compliance

* Risk-based thinking must extend across the entire quality system

* Internal audits and management reviews will face deeper FDA scrutiny

* MDSAP is helpful, but not sufficient

* A simple, well-structured Quality Plan demonstrates leadership and readiness

* QMSR presents a strategic opportunity for QARA professionals

Keywords

QMSR, FDA Quality System Regulation, ISO 13485, Risk-Based Thinking, MDSAP, FDA Inspection Readiness, Quality Plan, CAPA, Supplier Controls, MedTech Leadership

About Holly Cotter

Holly Cotter is a a biomedical engineer turned regulatory strategist with hands-on clinical roots and global MedTech experience. She has led regulatory, quality, and clinical initiatives across startups, large manufacturers, and consulting environments, with deep expertise in EU MDR, post-market surveillance, PMCF strategy, and FDA compliance.

Holly is also the Co-Founder of indieMedTech, a growing professional platform dedicated to connecting and empowering MedTech leaders. Through her consulting work and community building, she is helping companies navigate complex regulatory transitions - including the shift to QMSR - with clarity, structure, and risk-based thinking.

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.

Summary

“Risks occur. They happen but they don’t exist… hazards do.”

In this Let’s Talk Risk! conversation, host Naveen Agarwal sits with Jean Blom, a QMS & Audit Specialist and risk management trainer with deep experience across ISO 13485 auditing, ISO 14971 risk management (including usability), and certification/accreditation perspectives.

Our conversation is deliberately informal and highly practical. We explore why many teams get stuck in the mechanics of risk tools (especially large, bottom-up FMEAs), and how a shift toward hazard-first thinking can make risk management more tangible, especially for startups, early-career professionals, and teams working on diagnostic and software-driven devices.

Listen to the full 30-minute podcast or jump to a section of interest listed below.

Chapters

00:01 Introduction to Jean’s start in risk management02:45 Linear standards vs. real-world complexity05:20 Indirect harm in diagnostic and AI devices07:10 Risk management for start up and early career professionals10:30 Risks don’t exist, hazards do 13:20 Role of examples in risk management16:45 Risk information outside of risk management team 18:00 Why FMEAs fail at the executive view20:20 Risk management competence development21:00 Seek to be understood 23:40 Teaching risk without jargon26:40 From getting it right to not getting it wrong

If you enjoyed this podcast, consider subscribing to the Let’s Talk Risk! newsletter.

Suggested links:

LTR: Why FMEA Alone is Not Sufficient for Risk Analysis.

LTR: Three Pillars for Defining Your IVD Risk Management Strategy.

LTR: Focus on Intended Use for IVD Risk Management.

Key Takeaways

* When just starting with risk management, begin with hazards: they are tangible and controllable; “risk” is an outcome.

* Standards provide structure, but real-world risk is non-linear and contextual.

* Diagnostic and AI devices shift risk focus from physical harm to information.

* The instructions for many legacy risk tools (like FMEA) were built for projects and missions, not full lifecycle thinking.

* Large FMEAs, even summarized, do not provide meaningful executive insight.

* Jargon blocks learning; effective training must be adapted to experience level.

* Risk capability evolves: from first learning to get it right, to continue training to not being able to get it wrong.

Keywords

Hazards, Hazardous Situations, ISO 14971, ISO 13485, Risk Management Training, FMEA Limitations, Diagnostic Device Risk, Usability Engineering, ISO 62366-1, Systems Thinking, Benefit–Risk, Risk Communication, Startup QMS

About Jean Blom

Jean Blom is Netherlands-based QMS & Audit Specialist and Quality Manager (Medical Devices) with extensive experience guiding teams through ISO 13485 quality systems, auditing (ISO 19011), and ISO 14971 risk management, including usability. He has served as a Technical Assessor/Technical Expert for ISO 17021-1 accreditation activities related to ISO 13485 certification bodies and has supported global QMS compliance across multiple markets and device types.

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.

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.

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.

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.

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.

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.

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