Summary“EU MDR is the spiritual ancestor of the EU AI Act”.In this Let’s Talk Risk! conversation, host Naveen Agarwal welcomes Kevin Schawinski, astrophysicist turned AI entrepreneur and CEO of Modulos AG. Kevin shares his journey from studying black holes to building AI governance solutions, and explains how the EU AI Act is modeled after the EU Medical Device Regulation (MDR). He highlights the parallels between product safety regimes in MedTech and emerging AI regulation, offering practical insights for organizations preparing for compliance.The conversation explores ISO 42001 as a baseline AI management system standard, the implications of fine-tuning large models, and why medical device professionals may actually be better prepared than most industries to navigate AI regulation. Kevin emphasizes the importance of responsible deployment across culture, processes, and technology, and leaves listeners with a clear message: MedTech organizations already have the tools and mindset to take a leadership role in shaping trustworthy AI.Listen to the full 30-minute podcast or jump to a section of interest listed below. Chapters00:10 Introducing Kevin Schawinski - From Black Holes to AI03:29 How EU AI Act Parallels EU MDR07:00 MedTech Readiness for AI Compliance11:00 Defining and Building Responsible AI20:13 Managing Risks Across Supply Chain23:19 Announcements and Key TakeawaysIf you enjoyed this podcast, consider subscribing to the Let’s Talk Risk! newsletter.Suggested links:LTR: Contrasting US and EU Approaches to AI Regulation.LTR: Eight Practical Actions to Future-Proof Your AI Enabled Medical Devices.ACHIEVE: PMS Workshop.Key Takeaways* The EU AI Act mirrors MDR’s risk-tiered framework.* MedTech pros are better prepared than most for AI rules.* ISO 42001 is the new baseline for AI management.* 42001 helps, but doesn’t ensure AI Act compliance.* Fine-tuning AI models shifts full responsibility to you.* Responsible AI needs culture, process, and tech alignment.* EU and U.S. AI laws are moving fast but differ in approach.* U.S. states push ahead, driving calls for federal law.* AI supply chains create hidden liability risks.* MedTech can lead in trustworthy AI using existing practices.KeywordsEU AI Act, MDR, Risk-tiering, ISO 42001, Compliance, Liability, Fine-tuning, Responsible AI, Trustworthy AI, Supply chain, MedTech, GovernanceAbout Kevin SchawinskiKevin Schawinski is the Co-Founder & CEO of Modulos AG, where he leads the development of AI governance solutions that align with global standards such as the EU AI Act and the U.S. NIST AI Risk Management Framework. An astrophysicist turned entrepreneur, he previously served as an assistant professor at ETH Zurich, published in leading journals like Nature and Science, and pioneered the use of machine learning in astrophysics. Today, Kevin contributes to international AI policy efforts with NIST and the European Commission, advocating for responsible and trustworthy AI innovation.Let’s Talk Risk! with Dr. Naveen Agarwal is a 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.DisclaimerInformation 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
In this audio brief, We unpack an academic study that compares the EU’s MDCG 2019-16 and the FDA’s cybersecurity guidance, benchmarking them against international best practices. Both documents cover the basics, but each leaves troubling gaps, especially in areas like authentication, secure coding, network security, and resilience.Key points in this audio brief:* The biggest risks of connected medical devices and why cybersecurity is now inseparable from patient safety.* Where the EU and FDA guidance converge, and where they diverge.* Thematic gaps: authentication, cryptography, secure coding (EU) vs. network security and resilience (FDA).* Why existing vulnerabilities often stem from implementation failures, not policy gaps.* A proposed structural fix: separating high-level principles from device-specific technical guidance.* How stronger enforcement or penalties could change manufacturer behavior.For professionals in regulatory affairs, risk management, and MedTech development, this conversation highlights where guidance is falling short, and what’s needed to drive consistent, secure practices across the industry.🎧Listen to the audio brief above for an overview of the AI/ML device recalls, emerging vulnerabilities and trends to watch. Thanks for reading Let's Talk Risk!. This post is public so feel free to share it.Note:This audio brief was prepared using Google NotebookLM, an AI-enabled research tool. Here is the list of resources used in our analysis:* Cybersecurity requirements for medical devices in the EU and US - A comparison and gap analysis of the MDCG 2019–16 and FDA premarket cybersecurity guidance, Research Letter | Computational and Structural Biotechnology Journal, July 2025.This summary was created using ChatGPT-5 (September 2025) with expert review. It distills publicly available information on EU and FDA cybersecurity guidance for medical devices. While reviewed for accuracy and relevance, it does not constitute legal, regulatory, or medical advice. Cybersecurity in healthcare is a rapidly evolving field, and details may change after publication.We encourage listeners to interpret these findings in the context of these constraints. 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
Summary“Wireless coexistence is not a checkbox. It’s a risk management approach”.In this Let’s Talk Risk! conversation, Dr. Naveen Agarwal sits down with Omar Al Kalaa, PhD, Founder of Inovectrum and former FDA wireless scientist, to explore the challenges and opportunities of integrating wireless technology into medical devices. Omar shares his journey from academic research on wireless coexistence to leading FDA initiatives on 5G-enabled medical devices, offering a unique perspective at the intersection of MedTech, telecom, and regulatory science.The conversation covers key issues manufacturers face when adopting wireless connectivity, such as defining quality of service, assessing risk categories, and ensuring coexistence in crowded spectrum environments. Omar explains why medical devices must be viewed as connected systems rather than standalone products, highlighting risks from Bluetooth- and Wi-Fi-enabled devices, lessons from real-world recalls, and the growing need to integrate safety, cybersecurity, and interoperability into design. His takeaways emphasize a holistic, systems-based approach to innovation and evaluation in connected healthcare.Listen to the full 30-minute podcast or jump to a section of interest listed below. Chapters01:00 Omar’s Journey - From Academia to FDA to Entrepreneurship03:35 Understanding First Principles of Wireless in MedTech06:14 Risk Categories for Wireless Functions08:16 Understanding Wireless Coexistence13:00 Thinking in Systems, Not a Stand Alone Device15:35 Real-World Recall Example19:17 Wireless Immunity and 5G24:42 Announcements, Key Takeaways and Closing ThoughtsIf you enjoyed this podcast, consider subscribing to the Let’s Talk Risk! newsletter.Suggested links:LTR: A new paradigm for building connected medical devices.LTR: FDA guidance on interoperable devices.ACHIEVE: PMS Workshop.Key Takeaways* The FDA wireless guidance is crucial for incorporating wireless technology.* Understanding the risk category for wireless functions is essential.* Wireless coexistence is a risk management approach, not just a checkbox.* Medical devices should be viewed as interconnected systems.* Cybersecurity must be considered alongside other technical aspects.* Evaluating the end-to-end system is vital for safety and performance.* Device manufacturers should consult relevant technical documents for guidance.* The introduction of new technologies requires updated evaluation standards.* Communication between devices can impact performance and safety.* A holistic approach is necessary for effective risk management.KeywordsMedical devices, wireless technology, risk management, FDA guidelines, wireless coexistence, medical systems, cybersecurity, connectivity, healthcare innovation, regulatory complianceAbout Omar Al KalaaOmar Al Kalaa is the Founder and Principal of Inovectrum, a technology practice bridging MedTech and telecom through wireless innovation. He helps companies design and deploy high-performance connectivity solutions for medical devices, clinical environments, and digital health systems.Before founding Inovectrum, Omar spent over eight years at the FDA, where he led regulatory science initiatives on 5G-enabled medical devices, developed wireless coexistence standards, and guided industry on complex compliance challenges. With a PhD in Electrical and Computer Engineering from the University of Oklahoma, he combines deep technical expertise with regulatory insight to advance future-ready connected health technologies.Let’s Talk Risk! with Dr. Naveen Agarwal is a 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.DisclaimerInformation 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
Summary“Management listens when you connect patient risk to product requirements and business goals.”.In this Let’s Talk Risk! conversation, host Naveen Agarwal and Richard Matt delve into the complexities of communicating risk to senior executives. They explore the common challenges faced by risk practitioners in effectively conveying risks and the importance of framing these discussions in terms of both risks and benefits. Richard shares his experiences and insights on building trust, engaging middle management, and the evolving definitions of benefits in risk management. The discussion emphasizes the need for clear communication, prioritization of patient safety, and the integration of project and patient risks to foster better decision-making and collaboration within organizations.Listen to the full 30-minute podcast or jump to a section of interest listed below. Chapters00:10 Introducing Richard Matt02:01 Understanding the Communication Breakdown05:02 Connecting Technical and Management Perspectives06:16 Effective Communication Strategies in Risk Management09:12 Navigating Middle Management Dynamics15:50 The Importance of Framing Risks and Benefits17:07 Expanding the Definition of Benefits in Risk Management20:31 Authority and Credibility in Risk Management23:05 Announcements, Key Takeaways and ConclusionIf you enjoyed this podcast, consider subscribing to the Let’s Talk Risk! newsletter.Suggested links:LTR: Communicate to facilitate collaboration, not to impose opinions.LTR Webinar: Benefit-risk evaluation of an AI/ML enabled device.ACHIEVE: FMEA workshop.Key Takeaways* Communication with management about risks is crucial.* Integrating project risks with patient risks enhances understanding.* Building trust is essential for effective collaboration.* Early communication prevents crises from escalating.* Understanding leadership concerns helps frame discussions.* Middle management dynamics can complicate risk communication.* Framing risks in terms of benefits is vital for engagement.* Simplifying risk management practices can improve efficiency.* Authority in risk management comes from expertise, not just position.* Listening to customer complaints provides valuable insights.KeywordsRisk communication, senior executives, risk management, patient safety, project management, collaboration, trust, benefits, medical devices, leadershipAbout Richard MattRichard 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 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.DisclaimerInformation 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
Note: this is an updated version of the original article first published on Sep 8. It has been corrected for an error in the number of AI/ML enabled medical devices cleared by the FDA mentioned in the original article.In this audio brief, we unpack recalls data on AI/ML enabled medical devices to gain insights on emerging vulnerabilities from a risk management point of view. Here are a few key highlights* The Landscape: 1,247 FDA cleared AI/ML devices across 155 product codes; 38 recall events identified for a deep dive.* Recall Severity: Mostly Class II recalls, no Class I recalls.* Leading Causes: * Software and algorithm errors (e.g., incorrect dose calculations).* Data integrity issues (e.g., misfiled or missing images).* Hardware failures (e.g., loose CT table bolts).* Labeling & approval lapses (e.g., unapproved software versions).Four-tier, risk-based system; stringent requirements for high-risk systems (including many medical devices); compliance timelines of 1–3 years.* Trends to Watch: * High rate of recalls within 12 months of clearance.* Devices without clinical validation face more, and larger, recalls.* Public companies account for nearly all recalled units, suggesting market pressures for faster launches without adequate clinical validation. * Takeaways for stakeholders: * Manufacturers: Strengthen lifecycle controls, prioritize pre-market validation, enhance post-market vigilance.* Regulators: Consider time-limited approvals and stronger oversight of high-volume AI devices.* Clinicians: Validate AI results with clinical judgment—trust but verify.* Patients: Benefit from innovation but remain vulnerable; safety must remain paramount.AI in MedTech is transformative but not without risk. The challenge is moving from compliance - driven recall response to active risk mitigation for robust safety and effectiveness. 🎧Listen to the audio brief above for an overview of the AI/ML device recalls, emerging vulnerabilities and trends to watch. Thanks for reading Let's Talk Risk!. This post is public so feel free to share it.Note:This audio brief was prepared using Google NotebookLM, an AI-enabled research tool. Here is the list of resources used in our analysis:* JAMA: Early Recalls and Clinical Validation Gaps in Artificial Intelligence - Enabled Medical Devices, Research Letter | AI in Health Policy, August 2025.* AI/ML Recalls Analysis - Unpublished report, created using ChatGPT. This summary was created using ChatGPT-5 (September 2025) with expert review. It distills publicly available information on FDA-cleared AI/ML-enabled devices and related recall patterns. While reviewed for accuracy and relevance, it does not constitute legal, regulatory, or medical advice. AI in healthcare is a rapidly evolving area, and details may change after publication.We encourage listeners to interpret these findings in the context of these constraints. 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
Summary“The PSUR should be a snapshot showing if your medical device is really safe, not just a 200-page report for auditors”.In this Let’s Talk Risk! conversation, host Naveen Agarwal sits down with Tibor Zechmeister, Head of Quality and Regulatory at Flinn.ai, to unpack the complexities of the Periodic Safety Update Report (PSUR) under EU MDR. They discuss key takeaways from the RAPS Euroconvergence Conference, the real-world challenges of estimating device usage, and why PSUR must be treated as a living process tied to risk management. Tibor also shares common audit pitfalls, best practices for compliance, and how automation tools - and even AI - are reshaping the future of PSUR reporting.Listen to the full 30-minute podcast or jump to a section of interest listed below. Chapters00:15 Introducing Tibor Zechmeister01:05 Insights from RAPS Euroconvergence Conference03:17 Understanding PSUR Requirements in MDR05:40 Challenges in Estimating Device Usage10:18 The Role of Software in Medical Devices13:43 Regulatory Intent Behind PSUR Requirements17:16 Common Audit Findings in PSUR Compliance21:01 Best Practices for Integrating PSUR with Risk Management23:45 Automation Tools for PSUR Development28:02 Announcements, Key Takeaways and ConclusionIf you enjoyed this podcast, consider subscribing to the Let’s Talk Risk! newsletter.Suggested links:LTR: Databases and Automation Tools for Clinical Evaluation.MDCG 2022-21: Guidance on Periodic Safety Update Report (PSUR) according to Regulation (EU) 2017/745, updated as of December 2022..ACHIEVE: Post-Market Surveillance Workshop.Key Takeaways* The PSUR is a snapshot to assess device safety.* MDCG guidance should be followed for best practices.* PSUR should be a continuous, interrelated process.* Collaboration among industry stakeholders is essential.* Understanding the regulatory intent behind PSUR is crucial.* Estimation of device usage can be challenging.* Software as a medical device requires careful tracking.* Automation tools can enhance PSUR development efficiency.* PSUR is not just a regulatory requirement, but a safety measure.* Effective communication with regulatory bodies is key.KeywordsPSUR, MDR, medical device regulation, risk management, post-market surveillance, compliance, software as a medical device, regulatory challenges, best practices, automation toolsAbout Tibor ZechmeisterTibor Zechmeister is Head of Regulatory and Quality at Flinn.ai and a MedTech entrepreneur with nearly 15 years of experience spanning medical devices, software, and regulatory compliance. He has founded multiple companies, advised startups, and serves as a Notified Body auditor across Europe. At Flinn.ai, he helps manufacturers harness AI and automation to simplify regulatory processes and improve patient safety. With a background in biomedical engineering and an MBA, Tibor brings a rare mix of technical depth, regulatory expertise, and entrepreneurial vision to the future of MedTech.Let’s Talk Risk! with Dr. Naveen Agarwal is a 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.DisclaimerInformation 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
This is a free preview of a paid episode. To hear more, visit naveenagarwalphd.substack.comSummary“Don’t wait. You need time not just to update your procedures, but to generate the records FDA will expect to see the day they walk through your door.” In this episode of the Let's Talk Risk Podcast, host Naveen Agarwal and Michelle Lott from Lean RAQA discuss the upcoming Quality Management System Regulation (QMSR) for medical devices, emphasizi…
In this audio brief, we unpack the rapidly evolving AI regulatory landscape in the U.S. and EU. While the U.S. emphasizes rapid innovation with lighter-touch oversight, the EU is implementing a strict, risk-based framework.Here are a few key highlights* U.S. AI Action Plan (July 2025): Prioritizes speed, innovation, and global leadership; promotes a “try first” culture; frames AI as a national security imperative.* FDA Guidance: Good Machine Learning Practices, predetermined change control plans, and lifecycle management for adaptive AI in medical devices.* EU AI Act: Four-tier, risk-based system; stringent requirements for high-risk systems (including many medical devices); compliance timelines of 1–3 years.* Strategic Impact: Global companies must navigate divergent compliance pathways — innovation speed vs. upfront safety guarantees.* Professional Development Tips: Stay informed, understand AI fundamentals, think globally, and develop AI-specific quality, regulatory, and risk management skills.The regulatory choices made today will shape not only innovation timelines but also how safely and ethically AI integrates into healthcare. Professionals who understand both U.S. and EU approaches will be best positioned to navigate and influence the future.🎧Listen to the audio brief above for an overview of the contrasting visions and strategies in the U.S. and EU for AI regulation.Thanks for reading Let's Talk Risk!. This post is public so feel free to share it.Note:This audio brief was prepared using Google NotebookLM, an AI-enabled research tool. Here is the list of resources used in our analysis:* The White House: Americas AI Action Plan, issued July 2025.* US Congress: Regulating Artificial Intelligence: U.S. and International Approaches and Considerations for Congress, Report number R48555, issued June 2025. * FDA: Artificial Intelligence in Software as a Medical Device, website accessed on August 10, 2025. * Future of Life Institute: High-level summary of the AI Act, Issued February 2024.The text summary was created using ChatGPT-4o (May 2024) with expert review. It summarizes publicly available sources on emerging U.S. and EU AI regulation approaches. While reviewed for accuracy and relevance, it is not legal or regulatory advice. AI regulation is rapidly evolving, and details may change after publication. We encourage listeners to interpret these findings in the context of these constraints. 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
Summary“The opportunities in India’s MedTech sector are tremendous. Start networking, join incubators and get involved!”In this Let’s Talk Risk! conversation, host Naveen Agarwal engages with Attrayee (Atty) Chakraborty, a quality systems engineer specializing in regulatory affairs. They discuss the rapidly evolving medical device landscape in India, the importance of networking for young professionals, and the comparison of Indian medical regulations with global standards. Atty shares insights on domestic innovation, government support, and the role of AI in healthcare, providing valuable advice for students and early career professionals looking to enter the medical sector.Listen to the full 30-minute podcast or jump to a section of interest listed below. Chapters00:22 Introducing Attrayee (Atty) Chakraborty03:42 The Evolving Landscape of Medical Devices in India05:58 Domestic Innovation and Government Support09:04 Career Opportunities for Young Professionals in India14:45 Comparing Indian Regulations with Global Standards18:02 The Role of AI in India's Medical Sector21:55 Advice for Students and Early Career Professionals24:50 Closing Comments, Announcements and Key TakeawaysIf you enjoyed this podcast, consider subscribing to the Let’s Talk Risk! newsletter.Suggested links:LTR: What QA/Ra Professionals Need to Know About Rapidly Growing MedTech in India. ABLE: Association of Biotechnology Led Enterprises.ACHIEVE: Post-Market Surveillance Workshop.Key Takeaways* The medical device industry in India is evolving rapidly.* Networking is crucial for career advancement in regulatory affairs.* Government support is fostering innovation in the medical device sector.* AI is becoming increasingly important in India's healthcare landscape.* Young professionals should seek out incubators and accelerators for support.* Understanding global regulations can enhance credibility in the industry.* Simplicity and cost-effectiveness are key in Indian medical devices.* Engaging with startups can provide unique insights into problem-solving.* Participating in conferences can expand professional networks.* Taking initiative is essential for career growth in the medical field.KeywordsMedical devices, regulatory affairs, India, innovation, career guidance, AI in healthcare, quality management, healthcare regulations, startups, networkingAbout Attrayee ChakrabortyAttrayee Chakraborty is a quality and regulatory leader specializing in digital health and AI-enabled medical devices. At Analog Devices, she drives QMS development, risk management, and AI governance to meet global regulatory standards. Recognized as Quality Magazine’s 2025 “Rookie of the Year” and a 2025 RAPS Rising Star, Attrayee has delivered talks at major industry events including RAPS, MDM West, and ISPE. She also serves on working groups with IEEE, RAPS, and SQA, shaping the future of healthcare AI compliance. Passionate about empowering early-career professionals, she bridges the gap between regulatory rigor and real-world innovation. Let’s Talk Risk! with Dr. Naveen Agarwal is a 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.DisclaimerInformation 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
This is a free preview of a paid episode. To hear more, visit naveenagarwalphd.substack.comSummary“In this world that is changing really fast, your greatest superpower is your ability to learn new things.” In this episode of the Let's Talk Risk Podcast, host Naveen Agarwal and guest Dr. Jay Vaishnav discuss the dynamic regulatory landscape in the MedTech industry, particularly focusing on AI-powered medical devices. They explore the concept o…
In this audio brief, we unpack a recent Class I recall of Medtronic's Newport HT70 and HT70 Plus ventilators. These portable ventilators posed a grave risk—shutting down unexpectedly, potentially endangering patients on life support.But the story doesn't stop there.We take you inside the analytical process, examining over 2,000 adverse event reports from the FDA’s MAUDE database, and revealing early warning signals going back five years. Through deep narrative review, we uncover overlooked patterns of patient harm and compare this event with a similar capacitor-related recall involving Medtronic’s Puritan Bennett 980 (PB980) ICU ventilator.This 15-minute episode covers:* 🚨 The critical failure mode and what made it so impactful* 🕵️♂️ How injury signals were buried in "malfunction" codes* 🔍 Comparative insights between HT70 and PB980 ventilator recalls* 🧠 Organizational decisions and how strategic priorities influenced recall actions* 💡 Key takeaways for quality, regulatory, and risk professionals: including how to better use narrative data, monitor slow-developing risks, and conduct cross-device analysisThis case study challenges us to think beyond checkboxes—to look at what data truly reveals, how companies respond differently to similar failures, and how we as professionals can improve surveillance and advocacy for patient safety.🎧Listen to a brief audio summary of this case above and lessons QA/RA and Risk professionals can apply in practice. Thanks for reading Let's Talk Risk!. This post is public so feel free to share it.Note:This audio brief is the result of a retrospective analysis conducted using ChatGPT-4o (May 2024 version) in close collaboration with a human expert. The analysis combined structured MAUDE data with deep narrative review across more than a decade of adverse event reports. Our approach followed a phased, hypothesis-driven process to identify early safety signals, quantify underreported harm, and evaluate differences in organizational response across two Medtronic ventilator recalls (HT70 and PB980).The insights presented were generated through iterative refinement with ChatGPT and were critically reviewed by a human expert for clinical relevance, methodological soundness, and editorial integrity. Key limitations—such as underreporting in the FDA’s MAUDE database and lack of access to internal company data—are acknowledged within the audio. We encourage listeners to interpret these findings in the context of these constraints.Specifically, the audio summary was prepared using Google NotebookLM, an AI-enabled research tool. Here is the list of resources used in our analysis:* FDA: Class I recall event 96774, Posted Date June 9, 2025, Newport HT70 and HT70 Plus Ventilators, accessed on 25 July 2025. * FDA: Class I recall event 76891, Posted Date April 10, 2017, Newport HT70 and HT70 Plus Ventilators, accessed on 25 July 2025.* FDA: Class I recall event 88987, Posted Date April 10, 2017, Puritan Bennett 980 Series Ventilator, accessed on 25 July 2025.* FDA: Newport HT70 Ventilator, K111146 summary, Issued December 1, 2011, accessed on 24 July 2025.* FDA: Puritan Bennett 980 Series Ventilator System, K131252 summary, Issued Feb 24, 2014, accessed on 24 July 2025. * Orca1.ai: MAUDE data extract for HT70 ventilators, 2013-2025, extracted on 24 July 2025.* Orca1.ai: MAUDE data extract for all ventilators, FDA Product Code CBK, 2019-2024, extracted on 24 July 2025.* Medtronic press releases, annual reports and other media coverage during 2020 - 2025 timeframe* Analyst Report (Unpublished): Iterative data analysis, insights and lessons learned, prepared with assistance from OpenAI ChatGPT-4o, guided by human expert, 24 July 2025. 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
Summary“When reviewing clinical evidence for off-label use, come up with a plan to systematically address it and build these processes into your SOPs.”In this Let’s Talk Risk! conversation, host Naveen Agarwal and Kristen Petersen discuss the complexities of off-label use in clinical evaluation, emphasizing its significance in the medical device industry. They explore the definitions, examples, and regulatory considerations surrounding off-label use, as well as the importance of documentation and collaboration among teams. The discussion highlights the potential benefits of off-label use for patient care while also addressing the need for risk management and monitoring to ensure safety and compliance.Listen to the full 30-minute podcast or jump to a section of interest listed below. Chapters00:15 Introducing to Kristen Petersen02:25 Understanding Off-Label Use: Definitions and Examples07:33 Understanding Off-Label Use in the Context of ISO 1497111:23 Opportunities and Challenges of Off-Label Use13:526 Documenting Off-Label Use in Clinical Evaluation Reports18:25 Reasons Behind Off-Label Use by Healthcare Professionals21:59 Regulatory Considerations for Off-Label Use23:45 Announcements, Key Takeaways and Closing RemarksIf you enjoyed this podcast, consider subscribing to the Let’s Talk Risk! newsletter.Suggested links:LTR: Understanding the notified body perspective on clinical evaluation. Team NB: Data generated from ‘Off-Label’ Use of a device under the EU Medical Device Regulation 2017/745.ACHIEVE: Post-Market Surveillance Workshop.Key Takeaways* Off-label use is when a device is used outside its intended use.* Understanding off-label use is crucial for regulatory compliance.* Risk management plays a key role in addressing off-label use.* Collaboration among teams is essential for effective monitoring.* Documentation of off-label use should be integrated into clinical evaluation reports.* Off-label use can provide opportunities for expanding indications.* Healthcare professionals sometimes use devices in unapproved and off-label ways to solve patient issues.* Regulatory bodies are increasingly recognizing the importance of monitoring and reporting off-label device use.* Ambiguous labeling can lead to unintentional off-label use.* Continuous monitoring of literature and adverse events is necessary.KeywordsOff-label use, clinical evaluation, medical devices, risk management, regulatory compliance, healthcare professionals, patient safety, documentation, post-market surveillance, medical writingAbout Kristen PetersenKristen Petersen is Manager – CER Specialist (Medical Devices) at Global Regulatory Writing & Consulting (GLOBAL), where she leads the development of Clinical Evaluation Reports (CERs) under EU MDR and MDD, having authored and overseen more than 50 such reports. With over eight years in the medical device industry, she helps organizations translate clinical data into regulatory-ready narratives and mentors teams on best MDR practices. She holds a Bachelor’s degree in Political Science and Government from Brigham Young University.Since this recoding, Kristen has transitioned to a new role as a Principal Medical Writer/ Clinical Evaluation Specialist at Johnson & Johnson MedTech (Shockwave Medical).Let’s Talk Risk! with Dr. Naveen Agarwal is a 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.DisclaimerInformation 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
Summary“You need to base your summary and conclusions based on facts, not assumptions. Work smarter, not harder.”In this Let’s Talk Risk! conversation, Dr. Queenita Fernandes shares her extensive experience in the healthcare industry, particularly in risk management and clinical evaluation. She emphasizes the importance of collaboration, leveraging technology, and the role of AI in enhancing clinical literature reviews and signal detection in adverse events. The discussion also highlights the need for effective communication through storyboarding and the proactive approach required in the medical device industry. Dr. Fernandes concludes with key takeaways that inspire risk practitioners to embrace change and work towards better patient outcomes.Listen to the full 30-minute podcast or jump to a section of interest listed below. Chapters00:13 Introducing Dr. Queenita Fernandes02:02 Personal Journey and Influences03:44 Literature Review from a Clinician's Perspective07:56 Integrate Clinical Perspective with Engineering to Design for Safety10:04 Working Smart with AI Tools for Reviewing Clinical Literature16:58 Using Storyboards for Effective Communication20:50 Embracing AI Tools to Facilitate Collaboration23:19 Imagining a Validated Real-Time AI System for Clinical Review25:43 Announcements, Key Takeaways and Closing CommentsIf you enjoyed this podcast, consider subscribing to the Let’s Talk Risk! newsletter.Suggested links:LTR: Databases and automation tools for clinical evaluation. LTR: Understanding the notified body perspective on clinical evaluation. ACHIEVE: FMEA Workshop.Key Takeaways* Think proactive and partner cross-functionally.* Embrace technology and work smart.* AI should be viewed as a tool, not a replacement.* People generally intend to do good things.* Literature review can be intimidating but manageable.* Engage healthcare professionals in decision-making.* Use storyboarding for effective communication.* Signal detection is crucial in adverse event reporting.* Collaboration is key in the medical device industry.* Always put the patient at the center of evaluations.KeywordsRisk management, healthcare, clinical evaluation, AI in healthcare, adverse events, medical devices, literature review, signal detection, technology in healthcare, collaborationAbout Queenita FernandesQueenita Fernandes is a physician executive and certified patient safety expert with over 20 years of experience in medical safety, post-market surveillance, and regulatory writing. Her background spans clinical medicine, nutrition, and leadership roles across the MedTech ecosystem.Queenita is known for her work in proactive PMS, systematic literature reviews, and benefit-risk analysis under EU MDR and FDA frameworks. She brings a unique ability to translate clinical insight into regulatory strategy, improving safety signal detection and patient outcomes.A frequent speaker at international conferences and webinars, she is a trusted voice on how to strengthen post-market processes through rigor, ethics, and cross-functional collaboration.Let’s Talk Risk! with Dr. Naveen Agarwal is a 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.DisclaimerInformation 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
FDA highlights the increasing relevance of cybersecurity in the context of medical device safety and effectiveness in the opening section of the final guidance issued on June 27, 2025:With the increasing integration of wireless, Internet- and network-connected capabilities, portable media (e.g., USB or CD), and the frequent electronic exchange of medical device-related health information and other information, the need for robust cybersecurity controls to ensure medical device safety and effectiveness has become more important.Further;In addition, cybersecurity threats to the healthcare sector have become more frequent and more severe, carrying increased potential for clinical impact. Cyber incidents have rendered medical devices and hospital networks inoperable, disrupting the delivery of patient care across healthcare facilities in the U.S. and globally. Such cyber incidents and exploits may lead to patient harm as a result of clinical hazards, such as delay in diagnoses and/or treatment.It is important to view FDA’s expectations outlined in this final guidance from the perspective outlined above. Cybersecurity is not an add-on; rather it is now considered to be an essential factor in assessing medical device safety and effectiveness throughout its total product lifecycle. A risk-based approach is recommended to compile documentation for pre-market review, and continued surveillance and actions in the post-market phase. 🎧Listen to a brief audio summary of this guidance and recommendations QA/RA and Risk professionals can apply in practice. Thanks for reading! If you liked this post, please share with others. Note:The audio summary was prepared using Google NotebookLM, an AI-enabled research tool. Here is the list of resources used for this analysis:* FDA: Final Guidance for Cybersecurity in Medical Devices, Issued June 27, 2025.* FDA: Draft Guidance for Cybersecurity in Medical Devices, Issued September 27, 2023.* FDA: Cybersecurity in Medical Devices Frequently Asked Questions, Website accessed July 01, 2025 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
Summary“A major change proposed in the draft of ISO 10993-1 revision is the focus on foreseeable misuse and effect of cumulative device use for biological safety. ”In this Let’s Talk Risk! conversation, host Naveen Agarwal engages with Priyanka Murawala, an expert in biological evaluation of medical devices. They discuss the latest updates on ISO 10993-1, the differences in regulatory approaches between the EU and the US, challenges faced in biological evaluation, significant recalls related to biocompatibility, and best practices for ensuring safety in medical devices. The conversation emphasizes the importance of risk assessment and the need for effective communication in the medical device industry.Listen to the full 30-minute podcast or jump to a section of interest listed below. Chapters00:15 Introducing Priyanka Murawala02:16 Key Focus in Revised ISO 10993: Foreseeable Misuse and Cumulative Use04:320 Comparing EU and US Regulatory Approaches to Biological Evaluation07:27 Challenges in Meeting Regulatory Expectations for Biological Evaluation11:49 Learning from Device Recalls 19:37 Considering Risk of Residual Processing Agents in Manufacturing22:45 Announcements, Key Takeaways and Closing CommentsIf you enjoyed this podcast, consider subscribing to the Let’s Talk Risk! newsletter.Suggested links:LTR: Focus on risk, not just testing for biocompatibility of medical devices. Nelson Labs: ISO 10993-1 Key update on the new revision of this critical standardACHIEVE: FMEA Workshop.Key Takeaways* ISO 10993-1 is being updated to focus on foreseeable misuse.* The EU and FDA have different approaches to biocompatibility evaluation.* Regulatory bodies often require extensive testing even for minor design changes.* Biocompatibility recalls highlight the importance of thorough risk assessment.* Involving biocompatibility experts early can improve safety outcomes.* Quality management systems should comply with ISO 13485 standards.* Post-market surveillance is crucial for learning from device performance.* Effective communication of risks is essential in medical device labeling.* Anticipating risks early in the design phase can prevent future issues.KeywordsBiocompatibility, risk assessment, foreseeable misuse, ISO 10993, medical devices, regulatory differences, FDA, EU, biological evaluation, recalls, best practicesAbout Priyanka MurawalaPriyanka Murawala a seasoned regulatory affairs expert and founder of Eunoia Compliance, where she helps medical device companies navigate FDA and EU MDR requirements with a focus on biocompatibility and quality systems. Priyanka holds a PhD in Physical and Materials Chemistry and has conducted postdoctoral research in regenerative medicine at TU Dresden. With deep expertise in ISO 10993 and ISO 13485, and a strong background in biomaterials and nanotechnology, she brings a unique blend of scientific insight and regulatory strategy to every project. Let’s Talk Risk! with Dr. Naveen Agarwal is a 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.DisclaimerInformation 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
This is a free preview of a paid episode. To hear more, visit naveenagarwalphd.substack.comSummary“The EU MedTech Shark Tank helps bring new technology ideas on a roundtable, pitching in front of physicians and investors to support startups by creating a network.” In this episode of the Let's Talk Risk Podcast, host Naveen Agarwal speaks with Dr. Michael Lichtenberg about the challenges and opportunities in bringing innovative medical devices…
Summary“MedTech in India is poised to generate $50 billion in revenues by 2030.”In this Let’s Talk Risk! conversation, host Naveen Agarwal engages with Sanjay Arudi, VP of Regulatory and Quality at GE Healthcare in India, to discuss the rapidly evolving MedTech environment in India. They explore the current state of the MedTech industry, government initiatives supporting healthcare, the regulatory landscape, and the importance of post-market surveillance. Sanjay shares insights on the challenges faced in regulatory compliance and offers career advice based on his extensive experience in the field. The conversation highlights India's potential to become a significant player in the global MedTech market by 2030.Listen to the full 30-minute podcast or jump to a section of interest listed below. Chapters00:20 Introducing Sanjay Arudi01:25 Current State of MedTech in India03:24 Government Initiatives and Domestic Manufacturing07:44 How Tariffs Might Impact MedTech Companies09:12 Regulatory Environment for Medical Devices14:06 Post-Market Surveillance and Reporting Requirements19:50 Regulatory Compliance Challenges in India22:33 Career Insights and Advice from Sanjay25:31 Announcements, Key Takeaways and Future OutlookIf you enjoyed this podcast, consider subscribing to the Let’s Talk Risk! newsletter.Suggested links:LTR: An exciting growth opportunity for MedTech in India. LTR: Navigating the regulatory landscape for SaMD in India. ACHIEVE: FMEA Workshop.Key Takeaways* India's MedTech industry is projected to generate 50 billion by 2030.* Government initiatives are crucial for expanding healthcare access.* 80% of medical devices in India are currently imported.* The CDSCO license facilitates entry into multiple markets.* Post-market surveillance is becoming increasingly important.* Regulatory compliance requires collaboration with regulators.* Transparency in reporting adverse events is essential for patient safety.* India's healthcare market is rapidly evolving post-COVID.* Investments in domestic manufacturing are on the rise.* Career success in regulatory roles requires active contribution and solution-oriented thinking.KeywordsMedTech, India, healthcare, regulatory environment, government initiatives, post-market surveillance, medical devices, industry growth, career advice, healthcare innovationAbout Sanjay ArudiSanjay Arudi is the Vice President of Regulatory and Quality at GE Healthcare. He has over 30 years of professional experience in engineering, management and senior leadership roles. His expertise includes product transfers, program management, implementation of Quality & Regulatory requirements across Design, Sourcing, Manufacturing, Install Base & Commercial activities. He has many years of experience in working with global regulators in creating a compliant & friendly manufacturing environment. He holds a Bachelor’s degree in Polymer Science & Technology. Let’s Talk Risk! with Dr. Naveen Agarwal is a 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.DisclaimerInformation 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
The DxI 9000 Access Immunoassay analyzer instrument and assays are used to diagnose serious conditions such as Hepatitis B and heart attacks, and to monitor levels of therapeutic drugs such as Digoxin used in treatment of heart failure and atrial fibrillation. In a recent warning letter, FDA cited several examples of incorrect severity assignments, Severity Rating has been incorrectly selected for many assays’ false result failure modes. Additionally, FDA found issues with procedures for CAPA, Nonconformances and Design Controls:* Criteria for escalating nonconformances to CAPA are not defined clearly* No process for assessing risk assessment of individual nonconformances * Severity classification of nonconformances released to the field is not adequately defined* No criteria for escalating complaints to CAPA based on trend analysis* CAPA actions are not verified and validated for effectiveness and additional adverse effect(s) on the finished devices* Inadequate procedures for verification and validation of design changes🎧Listen to a brief audio summary of this case above and lessons QA/RA and Risk professionals can apply in practice. Thanks for reading Let's Talk Risk!. This post is public so feel free to share it.Note:The audio summary was prepared using Google NotebookLM, an AI-enabled research tool. Here is the list of resources used for this analysis:* FDA: Warning letter, Beckman Coulter Inc., CMS 678042, March 15, 2024. * K011920, EMIT 2000 DIGOXIN ASSAY, MODEL OSR4H229, cleared July 2, 2001.* K121214, ACCESS ACCUTNI+3 REAGENT AND ACCESS ACCUTN1+3 CALIBRATORS FOR USE ON THE ACCESS 2 IMMUNOASSAY SYSTEM, cleared June 14, 2013.* K221225, Access TSH (3rd IS) Assay, DxI 9000 Access Immunoassay Analyzer, cleared November 10, 2022. * Beckman Coulter: Therapeutic Drug Monitoring Flyer FL-47564. 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
Summary“The 2025 conference was held in Amsterdam and it really was an amazing success.”In this Let’s Talk Risk! conversation, host Naveen Agarwal engages with Bijan Elahi, a leading authority in medical device safety risk management. They discuss the recent 2025 International Medical Device Safety Risk Management conference held in Amsterdam, focusing on the evolution of patient-centric safety, the importance of education in the field, and the key themes that emerged from the conference. Bijan shares insights on the future of medical device conferences and the need for collaboration and community support in advancing safety practices.Listen to the full 30-minute podcast or jump to a section of interest listed below. Chapters00:15 Introducing Bijan Elahi01:05 2025 International Medical Device Safety Risk Management Conference04:28 Growing Awareness of Patient Safety in MedTech07:21 Pre-Conference Education Day: Enhancing Knowledge10:40 Key Themes from the 2025 Conference12:51 Recognizing the Role of Physicians in Risk Management14:00 Looking Ahead: 2026 International Conference Planning17:19 Live Stream and Recording of Conference Presentations19:23 Support Needed for 2026 Conference22:30 Announcements, Key Takeaways and Closing CommentsIf you enjoyed this podcast, consider subscribing to the Let’s Talk Risk! newsletter.Conference Recordings:Conference recordings are available until Jul 31, 2025 at €99.5.Suggested links:LTR: Critical role of medical safety officer in medical devices. LTR: Tips for improving collaboration in risk management. ACHIEVE: FMEA Workshop.Key Takeaways* The 2025 conference in Amsterdam was a unique gathering of experts.* Patient safety should be the guiding principle in medical device design.* Education is crucial for enhancing knowledge in safety risk management.* AI and machine learning are becoming central topics in medical device safety.* Collaboration among professionals is essential for advancing safety practices.KeywordsMedical device, safety risk management, patient safety, international conference, education, AI, collaboration, healthcare, risk assessment, ISO 14971About Bijan ElahiBijan Elahi is the founder of MedTech Safety and a globally recognized expert on safety risk management of medical devices. Bijan is a technical fellow, and an affiliate professor at Drexel University, USA. Bijan is also a lecturer at Eindhoven University of Technology in the Netherlands, where he teaches risk management to doctoral students in engineering. He is a frequently invited speaker at international professional conferences, and is also a contributor to ISO 14971, the international standard on the application of risk management to medical devices. He has trained over 10,000 professionals worldwide and his book Safety Risk Management of Medical Devices, now in its second edition, is a bestseller.Let’s Talk Risk! with Dr. Naveen Agarwal is a 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.DisclaimerInformation 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
Summary“We still see companies having difficulty in accepting risk management as a tool for better decision making. Risk is often seen as a blocker rather than an enabler.”In this Let’s Talk Risk! conversation, host Naveen Agarwal and Brett Travaglio discuss the challenges and opportunities in risk management within the medical device industry. Key themes include cultural resistance to risk management, the importance of clear roles and responsibilities, the integration of project management principles, and the evolving role of AI in enhancing risk management practices. The discussion emphasizes the need for training and collaboration among cross-functional teams to effectively navigate the complexities of risk management in a dynamic regulatory environment.Listen to the full 30-minute podcast or jump to a section of interest listed below. Chapters00:15 Introducing Brette Travaglio01:10 Organizational Barriers in Risk Management03:46 Training for Improved Team Collaboration08:34 Applying Project Management Skills for Excellence in Risk Management10:39 Improving Basic Understanding of Risk Management13:09 Navigating the Current Regulatory Chaos15:42 How AI-Assisted Reviews will Impact FDA Reviews19:17 Using AI to Prepare Regulatory Submissions24:12 Handling Device Deficiencies in Clinical Trials25:32 Using Ambient AI to Improve Healthcare Delivery26:49 Announcements, Key Takeaways and Closing CommentsIf you enjoyed this podcast, consider subscribing to the Let’s Talk Risk! newsletter.Suggested links:LTR: Collaboration that drives innovation, not delays.LTR: Tips for improving collaboration in risk management. ACHIEVE: FMEA Workshop.Key Takeaways* Cultural resistance is a significant barrier to effective risk management.* Risk management is often perceived as a tedious exercise.* Clear roles and responsibilities are crucial for effective risk management.* Training for collaboration is essential in cross-functional teams.* Project management principles can enhance risk management practices.* Understanding risk management standards is vital for compliance.* Companies should build internal strength to navigate regulatory challenges.* AI can provide valuable insights for risk management.* Training is necessary for effective AI integration.* Collaboration must be a conscious effort, not assumed.KeywordsRisk management, medical devices, regulatory affairs, AI in healthcare, project management, collaboration, training, quality assurance, risk assessment, industry challengesAbout Brette TravaglioBrette Travaglio is the President and Consultant for Drug, Medical Devices, Biologics and Combination Product Manufacturers at Quality Solutions Now (QSN). She has over 25 years of industry experience at leading organizations with expertise in R&D, quality, regulatory affairs, and process improvement. At QSN, she leads a team to provide hands-on project management and consulting services to drug, medical device, biologics, and combination product manufacturers. QSN’s proprietary process, qsnFLOW™, enables them to quickly deploy highly skilled professionals to tackle challenges with flexibility, scalability, and cost-effectiveness. She holds a Bachelors degree in Aerospace Engineering, and Masters in Business Administration and Industrial Engineering. Let’s Talk Risk! with Dr. Naveen Agarwal is a 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.DisclaimerInformation 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