LTR 122: Tibor Zechmeister on PSUR Best Practices
Let's Talk Risk! Podcast
- Published
- September 5, 2025
- Duration
- 32:48
- Summary source
- description
- Last updated
- Jul 5, 2026
Discusses ai.
Summary
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 disc…
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Show notes
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
Themes
- ai