Director Governmental Affairs
Elekta, Netherlands
Leo Hovestadt has over 30 years of international experience in the Medical Device industry and was involved in Europe since the start in 1991 with the Medical Device Directive (MDD), and he is now involved with the Medical Device Regulation (MDR) and the AI act. Leo is Director Governmental Affairs at Elekta. He chairs several professional workgroups. He is a specialist on the MDR, Clinical Evaluation, Artificial Intelligence, Data Management and Digital Health. Leo is a regular speaker on congresses, like the RAPS convergence and other conferences.
Leo represents industry associations as stakeholder for amongst others COCIR, DITTA and FME at regulator meetings such as IMDRF, WHO, GHWP, European Commision, EMA and others. He is stakeholder amongst others in the MDCG for Clinical Investigation and Evaluation, and for the NEN in Standardisation Groups for the AI act. He is also author of several publications, such as the MDR guide for Medical Device Software for the Dutch Government.
Decoding and Understanding Artificial Intelligence (AI) - EU AI implementation
Wednesday, October 8, 2025
2:15 PM - 3:15 PM EST
Structured Dialogues: 10 Effective Topics to Engage With Your Notified Body
Thursday, October 9, 2025
1:00 PM - 2:00 PM EST