Let's Talk Risk! Podcast

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.

Chapters

00:15 Introducing Tibor Zechmeister

01:05 Insights from RAPS Euroconvergence Conference

03:17 Understanding PSUR Requirements in MDR

05:40 Challenges in Estimating Device Usage

10:18 The Role of Software in Medical Devices

13:43 Regulatory Intent Behind PSUR Requirements

17:16 Common Audit Findings in PSUR Compliance

21:01 Best Practices for Integrating PSUR with Risk Management

23:45 Automation Tools for PSUR Development

28:02 Announcements, Key Takeaways and Conclusion

If 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.

Keywords

PSUR, MDR, medical device regulation, risk management, post-market surveillance, compliance, software as a medical device, regulatory challenges, best practices, automation tools

About Tibor Zechmeister

Tibor 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.

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

“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.

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.

Chapters

00:22 Introducing Attrayee (Atty) Chakraborty

03:42 The Evolving Landscape of Medical Devices in India

05:58 Domestic Innovation and Government Support

09:04 Career Opportunities for Young Professionals in India

14:45 Comparing Indian Regulations with Global Standards

18:02 The Role of AI in India's Medical Sector

21:55 Advice for Students and Early Career Professionals

24:50 Closing Comments, Announcements and Key Takeaways

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 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.

Keywords

Medical devices, regulatory affairs, India, innovation, career guidance, AI in healthcare, quality management, healthcare regulations, startups, networking

About Attrayee Chakraborty

Attrayee 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.

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

“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 analysis

This 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.

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.

Chapters

00:15 Introducing to Kristen Petersen

02:25 Understanding Off-Label Use: Definitions and Examples

07:33 Understanding Off-Label Use in the Context of ISO 14971

11:23 Opportunities and Challenges of Off-Label Use

13:526 Documenting Off-Label Use in Clinical Evaluation Reports

18:25 Reasons Behind Off-Label Use by Healthcare Professionals

21:59 Regulatory Considerations for Off-Label Use

23:45 Announcements, Key Takeaways and Closing Remarks

If 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.

Keywords

Off-label use, clinical evaluation, medical devices, risk management, regulatory compliance, healthcare professionals, patient safety, documentation, post-market surveillance, medical writing

About Kristen Petersen

Kristen 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.

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 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.

Chapters

00:13 Introducing Dr. Queenita Fernandes

02:02 Personal Journey and Influences

03:44 Literature Review from a Clinician's Perspective

07:56 Integrate Clinical Perspective with Engineering to Design for Safety

10:04 Working Smart with AI Tools for Reviewing Clinical Literature

16:58 Using Storyboards for Effective Communication

20:50 Embracing AI Tools to Facilitate Collaboration

23:19 Imagining a Validated Real-Time AI System for Clinical Review

25:43 Announcements, Key Takeaways and Closing Comments

If 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.

Keywords

Risk management, healthcare, clinical evaluation, AI in healthcare, adverse events, medical devices, literature review, signal detection, technology in healthcare, collaboration

About Queenita Fernandes

Queenita 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.

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.

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

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.

Chapters

00:15 Introducing Priyanka Murawala

02:16 Key Focus in Revised ISO 10993: Foreseeable Misuse and Cumulative Use

04:320 Comparing EU and US Regulatory Approaches to Biological Evaluation

07:27 Challenges in Meeting Regulatory Expectations for Biological Evaluation

11:49 Learning from Device Recalls

19:37 Considering Risk of Residual Processing Agents in Manufacturing

22:45 Announcements, Key Takeaways and Closing Comments

If 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 standard

ACHIEVE: 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.

Keywords

Biocompatibility, risk assessment, foreseeable misuse, ISO 10993, medical devices, regulatory differences, FDA, EU, biological evaluation, recalls, best practices

About Priyanka Murawala

Priyanka 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.

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.