To provide a comprehensive overview of the regulatory system and requirements for medical devices in Europe under the Medical Devices Regulation (MDR), including most recent developments and implementation timelines. As software and apps become increasingly important in the medical sector, the training will provide regulatory perspectives and hands on experience on questions related to software as medical device. Case studies and practical examples will complement the training.
Course leader
Karin Schulze, Head of Medical Devices, SFL
Miguel Cárdenas, Regulatory Associate Director Medical Devices, Novartis
Mithun Ratnakumar, Lead Expert Software Development, SaMD projects, Novartis
Sonja Lederhilger, Lead Human Factors Engineering, Novartis
More information can be obtained here.