Valicare GmbH

Medical Device Compliance

For manufacturers of medical devices, compliance with DIN EN ISO 13485 applies

Is your quality management system (QM) in compliance with the requirements of ISO 13485?

The QM system described by ISO 13485 is broadly similar to the requirements of ISO 9001.Nevertheless, there are differences which take into account the special features and quality requirements of medical devices and which must be observed when setting up a quality management system in accordance with ISO 13485. These include, above all, the creation of a development file and the quality management manual.

Regardless of whether it is a question of checking the ISO compliance of an existing system or planning, setting up and implementing a new QM system, our experts will advise, support and assist you actively and competently!

Depending on your needs, we offer consulting, processing of individual subtasks or complete implementation of the ISO 13485 system.