IMDRF 2023

Rolf Oberlin Hansen is the international representative for the Danish Medicines Agency when it comes to Software as Medical Device and Artificial Intelligence. He is currently a part of the New Technologies Working Group under the European commission, and partakes in multiple international collaborations (IMDRF AIMD and SaMD). Prior, he was working with Market Surveillance and Medical Device incidents.

Rolf has a background in Biomedical Engineering and Informatics, focusing on Machine Learning, physiological modelling and respiratory implications on the dynamics of the heart. Most of his research has been around novel approaches utilizing non-invasive and new technologies combined with user products to aid in diagnosis.