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

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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.

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