How to get the MDR certification for Artificial Intelligence Softwares?

Medical Device made Easy Podcast · Jan 19, 2021

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Artificial Intelligence. This is the topic of today’s podcast episode. We will help you understand how to place AI Software as a Medical Device in the EU Market with the new EU MDR 2017/745.

For that, I have with me Leon Doorn from Aidence who is explaining to us its journey to get EU MDR 2017/745 certified. You will first understand what is really artificial intelligence, then we will talk about the classification of SaMD or Software as Medical Devices.

Leon will also tell us what went well and what was really a struggle for him. We will also talk about the Notified Body…