LTR 83: Road to market for AI devices in the EU just got more complex

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LTR 83: Road to market for AI devices in the EU just got more complex

Deep insights from a conversation with Florian Tolkmitt.

Jan 15, 2025

∙ Paid

Summary

“Manufacturers that want to go to the European market, thinking about AI devices, it’s really important that you don’t look only at the MDR. You really have to look at the AI Act as well.”

In this episode of the Let's Talk Risk Podcast, Florian Tolkmitt discusses the rapidly evolving regulatory landscape for medical devices in Europe, particularl…

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Let's Talk Risk! with Dr. Naveen Agarwal

Every Friday, Dr. Naveen Agarwal leads a Let's Talk Risk! conversation with industry colleagues to discuss practical challenges and share best practices in risk management. In the highly regulated world of medical devices, most practitioners struggle with the "how" of risk management. Regulatory requirements are complex, confusing and ever changing. Establishing an effective risk management process that satisfies the scrutiny of regulators and auditors without creating barriers to innovation is a significant challenge in the industry. Dr. Agarwal believes that no single "expert" has all the answers, and it is only when we connect, share and learn from each other that we all become better. Let us keep learning together!

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