Within this first Medical Device Live Expert Session my guests were
- Karandeep Badwal
- Stefan Bolleininger
- Cesare Magri
- Adam Issacs Rae
First I asked them for some RANDOM news they wanted to share with the audience. So check that out. One of them was really interesting.
The discussion was on:
1- EU MDR deadline of May 26th, 2024. We passed this deadline so what happens now. We discussed on class I devices and the impact of the deadline...
2- Notified Body situation was reviewed through the survey that was issued. We know that Notified Bodies have some capacity now.
3- Artificial Intelligence in Medical Devices is starting to grow. We have a lot of guidance that are issued. We will review one jointly issued by the UK MHRA, US FDA, and Health Canada.
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► Social Media to follow
■ Monir El Azzouzi Linkedin: / melazzouzi
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#easymedicaldevice #medicaldevice #regulatorycompliance
00:00:00 Introduction
00:03:21 Random News
00:10:32 26 May 2024
00:29:14 Notified Body Situation
00:45:37 AI in Medical Device Software
00:58:22 Q&A
00:59:41 Conclusion
7 авг 2024
