TEAM NB published questionnaire on AI in medical devices
The European association for notified bodies, TEAM NB, recently published a Q&A document on artificial intelligence (AI) in the context of medical devices. The document contains questions relevant for reviewers who evaluate AI in devices. Please note the document should rather be seen as a guidance document for questions that an assessor will ask with the corresponding regulatory sources.
The questionnaire can be accessed here.
Source: TEAM NB