The intensive seminar "Manager Regulatory Affairs“ contains all contents for the qualification as "Manager Regulatory Affairs – TÜV". You demonstrate your competence in the areas of European medical device law according to Medical Device Regulation (2017/745, MDR) and management systems for medical device manufacturers (ISO 13485) and are able to carry out approvals of medical devices in the European Economic Area. You are familiar with the regulatory requirements for clinical evaluation, risk management (ISO 14971) and the necessary contents of the technical documentation.