Director Governmental Affairs EU
Elekta, Netherlands
Leo Hovestadt is EU Director Governmental Affairs at Elekta, with more than 30 years of experience in the medical device industry. Prior to his current position, Leo worked in RA and QA functions with companies such as Medtronic and Schick Technologies (part of Sirona). He was closely involved from the start with the FDA QSR, the EU (AI)MDD and the EU MDR. He is representing industry as stakeholder during the creation of EU MDCG and international IMDRF guidance and GHWP. He is chairing COCIR (EU MDR), NEN (ISO standards) and DITTA (International guidance) workgroups dealing with topics such as clinical investigation / evaluation, software as a medical device, risk management, artificial intelligence, interoperability, EMA and classification. He is a regular speaker at congresses and (co-) authored regulatory and scientific publications.
Wednesday, September 18, 2024
9:15 AM – 10:30 AM PDT
Artificial Intelligence – Medical Devices and IVD’s conformity Assessment and CE Marking
Thursday, September 19, 2024
3:15 PM – 4:15 PM PDT