Compliance with DIN EN ISO 13485 for manufacturers of medical devices

Ensure the quality of your medical devices by establishing a quality management system (QMS) with Valicare.

The QMS described by ISO 13485 is tailored to medical devices. It is similar to the requirements of ISO 9001 but significantly more extensive in terms of overall effort and implementation.

Special features must be observed when setting up a quality management system in accordance with ISO 13485 and mapped in the quality management manual. This includes the design documents and the development file for the respective medical device, as well as the verification and validation of the described design.

Efficient qualification, verification, and validation support

Due to our long experience in verification and validation of manufacturing processes for medical devices, we create the appropriate validation concept for your product based on current standards and regulations.

This includes the qualification of equipment and facilities. Our experts know exactly what is important and what is necessary and indispensable. According to our motto "as little as possible, as much as necessary", we ensure an efficient approach.

We support you with the implementation of the concept. The goal is to provide objective proof that your product meets all regulatory and customer requirements.

If personnel resources are required, we can also take over the temporary function of the quality management representative.

Additional medical device qualification services can be found here: Qualification for Medical Device Industry