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.
Digitale Transformation und Plattformen
Thorsten Prinz, VDE
Juri Rohde, FUSE-AI
Roland Wiring, CMS Hasche Sigle
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