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

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.

Om Podcasten

Deep meaningful discussions for Knowledge dissemination and constructive arguments, with a shared mission about making Healthcare AI-ready. I invite stakeholders such as clinicians, AI experts, industry personnel and regulatory personnel to talk about the translational aspects of AI research into patient care. Often we converse with my co-host Henry Krumb.