A Quality Management System (QMS) compliant to the new Medical Device Regulation EU 2017/745 (EU MDR) is an important pillar for developing and placing medical devices on the European market. The change from the Medical Device Directive to the Medical Device Regulation requires distinct adaptations of the QMS to comply with the Regulation.

The standard (EN) ISO 13485 is well known in the world of medical devices. After all, it was already commonly the basis for the certification of medical devices in accordance with EC directives and other regulatory systems worldwide.

However, EU MDR has defined additional requirements for quality management that must be considered. This training will guide through the requirements of (EN) ISO 13485 and additional EU MDR requirements and what in particular needs to be taken into account.