Pascal Wettstein: FDA or MDR? Where should SMEs go for their AI SaMD
AI-ready Healthcare - Podcast készítő Anirban Mukhopadhyay, Henry Krumb - Keddek
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.
