REGULATORY AFFAIRS under MDR
Companies wishing to place medical devices on the European market must establish, document, implement and maintain a quality management system (QMS) in accordance with the legal requirements for the manufacture of their products. The quality management system should be appropriate to the risk class and type of device and should ensure compliance with the requirements of the MDR. The requirements for a quality management system for medical device manufacturers are defined by the EN ISO 13485 standard “Medical devices – Quality management systems – Requirements for regulatory purposes”.
We advise and accompany you in the implementation, maintenance or revision of a quality management system in accordance with DIN EN ISO 13485. Please feel free to contact us if you have any questions about QMS!