Leo Hovestadt is EU Director Governmental Affairs, with more than 30 years of experience in the medical device industry at Elekta and Medtronic. Prior to his current position, Leo worked as International QA and RA director. He was involved from the beginning with the start of AIMDD directive and the MDR regulation. He is representing industry as stakeholder with the creation of European MDR guidance, and International IMDRF guidance. He is a regular speaker at congresses on clinical, artificial intelligence and other regulatory topics.