Practical Dive into AI, Machine & Deep Learning Regulatory Requirements within the EU MDR & Methods for Compliance

Leo Hovestadt​
Director Governmental Affairs EU
Elekta

Leo Hovestadt has over 25 years of experience in the Medical Device industry and was involved from the start with the EU MDD and now with the MDR. He has experience internationally (EU, USA, China, Japan) with a wide variety of devices like software, pacemakers, and capital equipment.

He drives the COCIR Clinical Investigation and Evaluation workgroup and he represents COCIR in EU commission workgroups on Clinical Evaluation. He is also involved in the IMDRF workgroup on Clinical Evaluation and PMCF. Additionally, he participates in working groups for creating guidance on PMS, Medical Device Software and Artificial Intelligence. He has written the MDR guide for Medical Device Software for the Dutch Government. He is also a regular speaker on congresses about Clinical Evaluation and Software.