Pascal Wettstein: FDA or MDR? Where should SMEs go for their AI SaMD

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Recorded04 Apr 2023

Publisheranchor.fm ↗

Handlerec:10662089

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Pascal Wettstein is the owner of QDC GmbH. He is the self-proclaimed "SME safari guide in the regulatory jungle." I highly recommend his rather sarcastic LinkedIn posts on European Medical Device Regulations. Beyond Europe, he has extensive knowledge about the 510K regulations in FDA.

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“What did the council decide on item 42?” — answered with the speaker and the moment.

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