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Rolf Oberlin Hansen, Biomedical Engineer

Senior Advisor
Danish Medicines Agency (DKMA)

Rolf Oberlin Hansen is Senior Advisor at the Danish Medicines Agency, where he leads national implementation of software and AI legislation for medical devices. He has been closely involved in shaping the EU AI Act and now co-chairs the EU working group developing guidance for its application and software in the medical device sector. Internationally, he represents the EU in IMDRF working groups on AI and software in medical technologies

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