Let's Talk Risk! Podcast

Where MedTech professionals gain clarity and confidence to navigate complex decisions.
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Let’s Talk Risk! brings together MedTech leaders and practitioners for thoughtful conversations on the challenges that shape risk, quality, innovation, and leadership. With 150+ episodes and more than 30K downloads, it helps professionals gain the clarity and confidence to lead through complex decisions. naveenagarwalphd.substack.com

  1. 3d ago

    LTR 164: Susan Neadle on Combination Device Risk Management

    Summary “ISO 14971 and ICH Q9 are not competing frameworks. They are asking different questions about risk.” In this episode of the Let’s Talk Risk! conversation, host Naveen Agarwal speaks with Susan Neadle, Principal Consultant and President of Combination Products Consulting Services, to explore what changes when medical device and pharmaceutical risk-management approaches come together in a combination product. ISO 14971 places strong emphasis on hazards, hazardous situations, harms, users, and safety. ICH Q9 approaches risk through a different lens, with a strong focus on product quality, process variability, critical quality attributes, and control strategies. Susan explains why neither perspective is sufficient by itself for a combination product—and why the real challenge is understanding the interactions among the drug, device, manufacturing process, user, environment, and lifecycle. They also discuss the work underway on ISO 24971-3, intended to provide practical guidance on integrating these approaches; how new hazards and hazardous situations can emerge from constituent-part interactions; what combination products mean for supplier controls; and the leadership judgment required when technical, business, and patient considerations converge. Listen to the full 25-minute podcast or jump to a section of interest listed below. Chapters 01:19 – What Are Combination Products?02:41 – Difference in Risk Management.05:06 – Why Meeting Specifications Is Not Enough08:40 – ISO 24971-3 and the Need for Practical Integration Guidance10:49 – Bridging Drug and Device Risk Management Mindsets13:17 – ISO 14971 and ICH Q9: Different Questions About Risk14:55 – Combined Use Systems, Interface Risks, and New Hazardous Situations18:01 – Interaction Risks Between Drugs, Devices, and Biologics19:33 – Leadership, Judgment, and Making Risk-Based Decisions22:03 – Supplier Controls and Sponsor Responsibility24:55 – Key Takeaways: Lifecycle Risk Management and Keeping the End User Safe If you enjoyed this podcast, consider subscribing to the Let’s Talk Risk! newsletter. Suggested links: LTR: Integrating purchasing controls across product lifecycle. LTR: FDA’s New Risk Lens Under QMSR. LTR: LTR Risk Coach - AI-Powered Decision Support Tool. Key Takeaways * ISO 14971 and ICH Q9 are complementary, not competing. They examine risk through different lenses, and combination products require both perspectives. * The unit of analysis becomes the combined use system. Looking separately at a drug and device can miss risks created by their interactions with each other, the user, manufacturing processes, and the use environment. * Specifications alone do not establish safety. Particularly on the device side, user interaction and lifecycle experience can reveal hazards even when the product continues to meet specification. * Interactions can create risks that do not exist within either constituent part alone. Material compatibility, degradation, adsorption, extractables and leachables, sterilization, and biologic interactions are examples discussed in the episode. * Lifecycle changes matter. Supplier changes, process changes, labeling changes, and post-market information can alter the risk picture and require reassessment of the complete system. * The sponsor owns the complete risk picture. Suppliers may have strong risk-management processes for their particular component or constituent part, but the sponsor remains responsible for understanding the complete combination product. * Risk management is not a document. It is an ongoing lifecycle process informed by the product, constituent parts, manufacturing process, users, and post-market experience. Keywords Combination products, ISO 14971, ICH Q9, ISO 24971-3, combined use systems, lifecycle risk management, supplier controls, human factors, benefit-risk assessment, post-market risk About Susan Neadle Susan Neadle MS, BS, FRAPS, FAAO, is Principal Consultant and President of Combination Products Consulting Services LLC and an internationally recognized expert in combination products, medical devices, digital health, risk management, quality, regulatory affairs, and product and process design. She brings more than 35 years of industry experience, including a 26-year career at Johnson & Johnson and leadership experience at Amgen. Susan chairs the AAMI Combination Products Steering Committee and has held leadership roles across numerous industry working groups. She is also an educator and author of The Combination Products Handbook: A Practical Guide for Combination Products and Other Combined Use Systems. Her career has included extensive work in combination-product quality and regulatory strategy, design controls, Quality by Design, criticality analysis, risk management, and lifecycle product development. 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. 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

    LTR 164: Susan Neadle on Combination Device Risk Management

  2. Sep 25

    Deep Dive: When the Risk Baseline and the QMS Both Break Down

    The baseline is completely broken and the iteration process is blind. FDA’s August 21, 2026 warning letter to Pensar Medical LLC illustrates a failure that goes well beyond incomplete documentation. The underlying risk-management foundation was weak. Risk-control verification remained incomplete for critical areas, and FDA reportedly found no design, process, or use-related FMEAs for the WoundPro product line. At the same time, key QMS processes were also failing. Key highlights covered in the audio: * Risk analysis was incomplete or missing. Critical risk controls remained unverified, and some products lacked the basic FMEAs required by the firm’s own procedures. * Design and software changes were poorly controlled. Multiple changes lacked adequate implementation records, including an engineering change order described simply as “clean up all code,” with no verification record showing what had actually changed. * Field corrections were not properly managed. Software rework performed in the field was not reported within the required timeframe. * CAPA was not functioning as a learning system. FDA found CAPA records with missing root-cause analysis, corrective actions, and effectiveness verification. In another case, a corrective action was never incorporated back into the risk analysis. * Post-market information was not being translated into effective action. A serious injury involving retained foam and surgical intervention was reported late and categorized as a malfunction rather than a serious injury. The central lesson is straightforward: A robust QMS needs both a reliable risk baseline and processes that continuously challenge, maintain, and improve that baseline. If the original risk analysis is weak, changes cannot be evaluated properly. If CAPA, complaint handling, change control, and post-market processes are weak, new information never strengthens the risk analysis. That is how individual weaknesses become a systemic quality failure.. Keywords: Pensar Medical, FDA Warning Letter, QMSR, ISO 13485, Risk Management, Risk Analysis, Design Change Control, CAPA, Medical Device Reporting, Quality Management System 🎧Listen to the Deep Dive for a closer look at how the Pensar warning letter shows the consequences when both risk management and the broader QMS fail to operate as a closed-loop system. Thanks for reading Let's Talk Risk!. If you liked this post, share with others. Note: The audio summary was prepared using Google NotebookLM, an AI-enabled research tool. Here are a few key resources used for this analysis: * FDA (2026). Warning Letter: Lion Street Medical, d/b/a Pensar Medical LLC (CDRH-MARCS-CMS 733015). 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

    Deep Dive: When the Risk Baseline and the QMS Both Break Down

  3. Sep 18

    Deep Dive: When FDA Qualifies the Ruler

    A qualified tool does not eliminate regulatory scrutiny. It eliminates the need to keep proving that the same ruler works. What if one of the biggest sources of friction in medical device development is not the device itself—but the tool being used to measure its performance? Historically, FDA evaluated many of these tools as part of individual device submissions. The Medical Device Development Tools (MDDT) program creates a different pathway: qualify a tool for a defined context of use, and sponsors can rely on that qualification in subsequent device development and regulatory submissions without having to repeatedly establish the tool’s suitability for that same use. This Deep Dive explores what that means for evidence generation, regulatory strategy, and medical device development. Key highlights covered in the audio: * Why MDDT exists: reducing repeated evaluation of the same measurement and assessment methods across device submissions. * Context of use is everything: qualification applies only within clearly defined boundaries for how, where, and for what purpose the tool is used. * Different forms of evidence: qualified tools can include clinical outcome assessments, biomarker tests, non-clinical assessment models, and other specialized tools. * From patient-reported outcomes to computational models: examples show how FDA is qualifying increasingly diverse ways of generating evidence. * A more predictable development strategy: the MDDT process allows developers to establish the scientific credibility of a tool before relying on it in future regulatory decisions. The important point is that MDDT qualification does not replace evaluation of the medical device itself. Instead, it can reduce uncertainty around something equally important: whether the method being used to generate the evidence is scientifically credible for its intended purpose. Keywords: FDA MDDT, Medical Device Development Tools, Context of Use, Regulatory Science, Clinical Outcome Assessments, Biomarker Tests, Non-Clinical Assessment Models, Computational Modeling, Evidence Generation, Medical Device Development 🎧Listen to the Deep Dive for a closer look at how FDA’s MDDT program can reduce repeated validation work, improve predictability, and change how medical device teams think about evidence-generation strategy. Thanks for reading Let's Talk Risk!. If you liked this post, share with others. Note: The audio summary was prepared using Google NotebookLM, an AI-enabled research tool. Here are a few key resources used for this analysis: * FDA (2026). Medical Device Development Tools (MDDT) Program Guidance & Qualified Tools Registry (CDRH-FD&C Act Section 507). * FDA (2024). Summary of Evidence and Basis of Qualification (SEBQ) for Apple Atrial Fibrillation History Feature. Apple AFib History Feature SEBQ Document (PDF) * FDA (2024). Premarket Approval Application (PMA) Review for Abbott Medical’s TriClip G4 System. FDA Advisory Committee Review Presentation (PDF) * FDA (2020). CDRH Qualification of the Kansas City Cardiomyopathy Questionnaire (KCCQ) as a Clinical Outcome Assessment Instrument.Listed in the FDA MDDT Qualified Tools Registry * FDA (2026). Qualification of MolecuLightDX Wound Measurement as a Medical Device Development Tool. MolecuLightDX MDDT Qualification Announcement 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

    Deep Dive: When FDA Qualifies the Ruler

  4. Sep 11

    Deep Dive: What FDA’s QMSR Warning Letters Are Revealing

    If you’re trying to manage risk in isolated silos, your quality management system is already obsolete. What happens when a supplier changes a device label without triggering design controls? When operators quietly rework nonconforming product? Or when serious post-market signals never make it back into the risk file? This Deep Dive examines recent FDA inspection and warning-letter examples through one common lens: the integration of risk management across the quality system. The cases illustrate how seemingly separate failures in supplier controls, manufacturing, complaints, nonconforming product, CAPA, and infrastructure can become connected risk-management failures under QMSR. Key highlights covered in the audio: * Why ISO 13485 Clause 7.1 is becoming so important — and how risk management increasingly connects multiple parts of the QMS. * Supplier changes can become risk-management events when labeling, intended use, or other product assumptions change without adequate escalation. * Undocumented shop-floor rework can hide risk signals, leaving management metrics looking healthy while process problems accumulate. * CAPA cannot work in isolation when environmental controls, process data, nonconformances, and risk analyses are disconnected. * A static risk file is no longer enough. Post-market experience, manufacturing changes, supplier issues, and emerging hazards must continually inform lifecycle risk management. The broader lesson is straightforward: QMSR is pushing companies away from managing compliance clause by clause and toward managing risk as an interconnected system. And that raises an important question for medical device organizations: When a new signal appears anywhere in your quality system, can it actually find its way back to the assumptions in your risk analysis? Keywords: QMSR, ISO 13485, ISO 14971, Risk Management, FDA Warning Letters, CAPA, Supplier Controls, Nonconforming Product, Design Changes, Lifecycle Risk Management 🎧 Listen to the Deep Dive for a closer look at what recent FDA QMSR warning letters reveal about the growing expectation to integrate risk management across the entire quality system. Thanks for reading Let's Talk Risk!. If you liked this post, share with others. Note: The audio summary was prepared using Google NotebookLM, an AI-enabled research tool. Here are a few key resources used for this analysis: * FDA (2026). Warning Letter to Koven Technologies, Inc. (MARCS-CMS 734643). * FDA (2026). Warning Letter to Linemaster Switch Corporation (MARCS-CMS 730215). * FDA (2026). Warning Letter to Nipro Renal Solutions USA, Corporation (MARCS-CMS 732874). * FDA (2026). Medical Device Inspection Citations Data (2025–2026 Log), Regulatory Inspection Dataset (Form FDA 483 Observations). 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

    Deep Dive: What FDA’s QMSR Warning Letters Are Revealing

  5. Sep 4

    Deep Dive: The PFAS Substitution Risk Paradox in Medical Devices

    FDA: There is no reason to restrict the continued use of fluoropolymers in medical devices. What happens when pressure to eliminate a material creates greater risk for the patient? This Deep Dive examines the growing regulatory tension around PFAS and medical-device fluoropolymers, and why evaluating substitution requires more than asking whether a material belongs to a broad chemical category. Key highlights covered in the audio: * Not all PFAS present the same risk. The discussion distinguishes small-molecule PFAS from large, biostable fluoropolymers such as PTFE and PVDF used in medical devices. * FDA’s position is supported by extensive clinical experience. Decades of use and a large ECRI review found no conclusive evidence of patient harm from PTFE. * Substitution can introduce new clinical hazards. Changes in friction, flexibility, chemical resistance, sealing, or coating integrity can directly affect device performance and patient safety. * This creates a substitution risk paradox. Eliminating one perceived material hazard may introduce more immediate risks such as reduced trackability, altered drug delivery, particulate shedding, or embolic complications. * The decision belongs inside risk management. Under ISO 14971, the key question is how substitution changes the device’s total risk profile—not simply whether the original material can be removed. * A defensible strategy requires evidence. Chemical characterization, toxicological assessment, clinical evidence, and post-market surveillance can support continued use of a proven material. Keywords: PFAS, Fluoropolymers, PTFE, Medical Devices, FDA, Material Substitution, ISO 14971, Benefit-Risk Assessment, Patient Safety, Risk Management 🎧 Listen to the Deep Dive for a closer look at why eliminating a perceived material hazard does not necessarily reduce the overall risk of a medical device. Thanks for reading Let's Talk Risk!. If you liked this post, share with others. Note: The audio summary was prepared using Google NotebookLM, an AI-enabled research tool. Here are a few key resources used for this analysis: * FDA (2026). PFAS in Medical Devices: What You Need to Know, FDA Web Resource, U.S. Food and Drug Administration * Regulatory Affairs Group (2026). EU PFAS Restriction for Medical Devices: REACH Timelines and Derogations, Strategic Industry Report, MedTech Regulatory Guide 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

    Deep Dive: The PFAS Substitution Risk Paradox in Medical Devices

  6. Aug 28

    Deep Dive: When Patient Preference Becomes Regulatory Evidence

    Patient preference is no longer a soft qualitative afterthought. What if a device carries significant risks, but patients are willing to accept them for a meaningful clinical benefit? This Deep Dive examines how FDA’s evolving approach to Patient Preference Information (PPI) can turn those tradeoffs into quantitative evidence for regulatory benefit-risk decisions. Key highlights covered in the audio: * PPI is not the same as a patient-reported outcome. PROs describe what patients experience. PPI asks what risks patients are willing to accept to obtain a particular benefit. * Risk tolerance can be quantified. Methods such as discrete choice experiments and threshold techniques can establish measures such as Maximum Acceptable Risk (MAR) and help define the level of benefit patients consider meaningful. * Study design matters enormously. Patient comprehension, health numeracy, neutral presentation of risk, attribute selection, statistical analysis plans, and appropriate visual communication can determine whether preference data are credible. * FDA engagement needs to happen early. The discussion highlights the importance of using the Q-Submission process to align on attributes, ranges, methodology, and statistical analysis before the study is conducted. * PPI can extend beyond premarket approval. Preference information may inform labeling, shared decision-making, post-market benefit-risk assessments, and other decisions across the total product lifecycle. Keywords: Patient Preference Information, FDA Guidance, Benefit-Risk Assessment, Risk Tolerance, Medical Devices, Discrete Choice Experiment, Maximum Acceptable Risk, Q-Submission, Total Product Lifecycle, Risk Management 🎧 Listen to the Deep Dive for a closer look at how patient preference is becoming part of the quantitative language of medical-device risk management. Thanks for reading Let's Talk Risk!. If you liked this post, share with others. Note: The audio summary was prepared using Google NotebookLM, an AI-enabled research tool. Here are a few key resources used for this analysis: * FDA (2026, March 30). Incorporating Voluntary Patient Preference Information over the Total Product Life Cycle, FDA Guidance Document, U.S. Food and Drug Administration Pure Global (2026, April 8). FDA 2026 Guidance on Voluntary Patient Preference Information, Strategic Industry Report, Pure Global 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

    Deep Dive: When Patient Preference Becomes Regulatory Evidence

  7. Aug 21

    Deep Dive: Designing Safety Into Autonomous Robotic Devices

    The vulnerability of the modern clinical lab is quite literally concentrated at the point of the needle. Clinical laboratories have automated almost everything after the blood reaches the tube. Yet one of the most common invasive procedures in healthcare still depends on a person finding a vein by sight and touch and manually inserting a needle. FDA’s De Novo authorization of Vitestro’s Aletta® may signal that this last major manual bottleneck is beginning to change. But this Deep Dive is about much more than a robot drawing blood. It explores a bigger question for anyone working in risk management, quality, regulatory, clinical, or medical-device development. What does it take to make an autonomous medical device safe enough to perform an invasive clinical procedure on its own? In this audio brief, we unpack how Aletta combines imaging, robotics, software constraints, clinical supervision, and layered fail-safes — and how FDA evaluated a technology for which no predicate existed before. The result is a fascinating case study in how risk management changes when a machine begins doing what previously required a trained human. Key highlights covered in the audio: * De Novo pathway: De Novo authorization was necessary because there was no existing predicate for autonomous robotic phlebotomy. * Risk controls built around autonomy: imaging, software constraints, movement detection and supervisory intervention create multiple layers of protection. * Clinical performance: the ADOPT study reported a 94.5% first-stick success rate when a suitable vein was identified, including strong performance in patients with obesity and difficult venous access. * Specimen quality: robotically collected samples demonstrated analytical equivalence for the laboratory parameters evaluated. * Patient acceptance: 90% reported similar or less pain than manual phlebotomy, while 82% preferred the robotic system or had no preference. * A different workforce model: FDA-authorized use allows one trained phlebotomist to supervise up to three devices simultaneously. Keywords: FDA De Novo, Aletta, Vitestro, autonomous medical devices, robotic phlebotomy, artificial intelligence, medical robotics, risk management, clinical evidence, human oversight, diagnostic testing, automation 🎧Click Play above to listen to a brief audio summary about this groundbreaking technology. Thanks for reading Let's Talk Risk!. If you liked this post, share with others. Note: The audio summary was prepared using Google NotebookLM, an AI-enabled research tool. Here are a few key resources used for this analysis: * Giesen LFP, Roest JA, et al. (2026, April 14). Performance, Safety, and Patient Experience of an Autonomous Robotic Phlebotomy Device: A Multicenter Trial, Clinical Chemistry (hvag029), Oxford Academic * FDA (2026, August 19). FDA Authorizes First-Of-Its-Kind Robotic Blood Draw Device, FDA News Release, FDA * Evidence-Based Medical Insight (2026, August 19). Clinical, Regulatory, and Operational Analysis of the Aletta Autonomous Robotic Phlebotomy System: A New Paradigm in Preanalytical Automation, Evidence-Based Medical Insight * Bristow, H. (2026, May 27). Robotic Phlebotomy Trial: What the Patients Said, The Pathologist 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

    Deep Dive: Designing Safety Into Autonomous Robotic Devices

  8. Aug 14

    LTR 163: FDA’s New Risk Lens Under QMSR

    Summary “I don't think it's as easy to outsource risk as it used to be. Risk is pervasive now.” In this episode of the Let’s Talk Risk! conversation, host Naveen Agarwal speaks with Allyson Mullen, Director at Hyman, Phelps & McNamara, P.C., about what FDA’s early enforcement activity under the Quality Management System Regulation (QMSR) may tell medical device manufacturers about the agency’s evolving expectations. Using the first warning letter discussed in the episode as a starting point, Allyson examines how FDA is citing risk management under ISO 13485 Clause 7.1 and, increasingly, looking at the broader requirement to apply risk-based thinking across QMS processes under Clause 4.1.2. The conversation explores why companies already certified to ISO 13485 should not assume they are fully prepared for an FDA inspection, how FDA inspections may differ from notified-body audits, and why post-market information must feed back into risk management. Naveen and Allyson also discuss the legal and contractual implications of the transition, particularly the importance of reviewing quality agreements and clearly defining responsibilities when activities are outsourced. Finally, Allyson offers practical perspective on responding to FDA 483 observations and warning letters during a period when both regulators and industry are adapting to a new inspection framework. Listen to the full 25-minute podcast or jump to a section of interest listed below. Chapters 01:17 – Introduction and Allyson Mullen’s Regulatory and Legal Background02:17 – FDA’s First QMSR Warning Letter and Its Risk Management Findings03:46 – How FDA’s Language Around Risk Is Changing Under QMSR05:10 – Risk Beyond Design Control: ISO 13485 Clause 4.1.207:42 – When FDA May Look Beyond Product Realization12:48 – Why ISO 13485 Certification May Not Be Enough14:59 – Legal Risks and the Importance of Updating Quality Agreements17:19 – What to Do When FDA May Have Gotten an Observation Wrong21:21 – Warning Letters and the Challenges of the QMSR Transition23:40 – Allyson’s Journey from Regulatory Affairs to Law26:10 – Key Takeaways: Risk, Outsourcing, and Quality Agreements If you enjoyed this podcast, consider subscribing to the Let’s Talk Risk! newsletter. Suggested links: FDA Law Blog: FDA’s First QMSR Warning Letters. LTR Deep Dive: First FDA Warning Letter Under QMSR. LTR: LTR Risk Coach - AI-Powered Decision Support Tool. Key Takeaways * Risk is becoming more pervasive under QMSR. FDA now has clearer regulatory pathways for examining risk beyond traditional design-control activities. * Clause 7.1 may only be the beginning. Product realization provides an obvious entry point, while ISO 13485 Clause 4.1.2 allows FDA to examine whether risk-based thinking is embedded throughout the QMS. * Post-market feedback must close the loop. Complaints, adverse events, recalls, and other post-market information need a defined pathway back into risk management. * ISO 13485 certification does not guarantee an easy FDA inspection. FDA may challenge the methods and reasoning behind risk-based decisions more deeply than organizations have experienced in traditional notified-body audits. * Risk cannot simply be outsourced. Manufacturers remain responsible for understanding and managing risk even when product-realization activities are performed by suppliers or contract manufacturers. * Review quality agreements now. Older agreements may assign responsibilities using the former QSR structure and may not adequately address obligations under ISO 13485 and QMSR. * A 483 is not necessarily the final word. Companies should carefully evaluate FDA observations, provide missing context, correct the record where appropriate, and respond with a complete factual narrative. * The transition creates challenges for both FDA and industry. Early warning letters and inspection observations will be important signals for understanding how FDA applies QMSR in practice. Keywords QMSR, FDA, ISO 13485, Risk Management, Quality Systems, FDA Inspections, Warning Letters, Quality Agreements, Post-Market Surveillance, Medical Devices About Allyson Mullen Allyson Mullen is a Director at Hyman, Phelps & McNamara, P.C., where her work brings together deep experience in FDA regulatory matters and law. Before joining the firm, she served as a Corporate Attorney and Principal Regulatory Affairs Specialist at Waters Corporation, a Senior Regulatory Affairs Specialist at Boston Scientific, and a Regulatory Affairs Associate at DePuy Mitek. She earned her J.D. from New England Law | Boston and began her career in regulatory affairs before transitioning into legal practice—giving her experience on both sides of regulatory and legal decision-making. 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. 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

    LTR 163: FDA’s New Risk Lens Under QMSR
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Let’s Talk Risk! brings together MedTech leaders and practitioners for thoughtful conversations on the challenges that shape risk, quality, innovation, and leadership. With 150+ episodes and more than 30K downloads, it helps professionals gain the clarity and confidence to lead through complex decisions. naveenagarwalphd.substack.com

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  • Creator
    Where MedTech professionals gain clarity and confidence to navigate complex decisions.
  • Years Active
    2023 - 2026
  • Episodes
    185
  • Rating
    Clean
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    © Naveen Agarwal, Ph.D.
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    Let's Talk Risk! Podcast

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