EU MDR 2017/745 Certificate (English) 2024-03-26

Certificate according Regulation (EU) 2017/745 on Medical Devices

This certificate confirms that the quality management system of IMAGE Information Systems Europe GmbH complies with Annex IX Chapter I and III of Regulation (EU) 2017/745 on Medical Devices.

The certificate applies to the design, production, and final product inspection/testing of Picture archiving and communication systems (EMDN Code: Z110603, Category: MDA 0315)

  • Version 2024-03-26