Regulatory Affairs for AI Applications in Medical Devices

The use of AI blurs the determination of classic software products because the training data alters the algorithm. Hence, all stakeholders are facing new challenges: the potentially continuing modifications as well as being very much depended on carefully selected training data. Therefore, currently AI algorithms need to be implemented in a frozen state in medical devices to receive clearance for US or EU market access.

Thorsten Prinz, VDE
Juri Rohde, FUSE-AI
Roland Wiring, CMS Hasche Sigle

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