Sebastian Fischer

Regulatory Strategy Principal at TÜV SÜD Product Service GmbH

Speaker

Sebastian is Regulatory Strategy Principal at the Medical & Health Services business of TÜV SÜD Product Service GmbH, a German notified body. There, his key responsibilities are communication and collaboration with European authorities (e.g. EMA, MDCG-NET) and associations (e.g. Team-NB). His focus is on digital medical devices, Artificial Intelligence and combination products. Before joining the notified body, he acted in similar function in pharmaceutical industry, where he additionally covered paediatric medicine development and the Japanese regulatory environment.Before switching to industry, he had research positions at the Max-Planck-Institutes for Intelligent Systems (Stuttgart) and Medical Research (Heidelberg). He did his studies in Bonn and Heidelberg, where he earned a Bachelor's degree in Biomedical Sciences and Master's degrees in Molecular and Cellular Biology (M.Sc.) as well as Drug Regulatory Affairs (MDRA).