To experience the full functionality of this website, cookies are needed. Please activate cookies and refresh your browser. After the refresh, a cookie management dialogue will be shown.

This website uses cookies for reasons of functionality, comfort, and statistics. You can change this setting at any time by clicking on “change settings”. If you consent to this use of cookies, please click “Yes, I agree”. Our privacy policy

ISO 13485 Compliance for Medical Devices

  • ISO Compliance Training
    next page

    ISO 13485 Compliance for Medical Devices

  • prefilled syringes
    next page

    ISO 13485 Compliance for Medical Devices

 
Content

In the medical device industry the quality management system is built in accordance with EN ISO 13485.

Valicare GmbH supports customers to be compliant with their management processes.

This comprises a GAP- or target-actual-analysis and the actualization of the quality management system according to the requirements of the Revision EN ISO 13845:2016. This is achieved by conceptual work and the development of documentation. For all business processes we apply a risk-based approach.

One of our main targets is the design control system. It is built by the steps design planning, design input, design output including verification and validation, design review, design transfer and design change control. The design history file covers the whole documentation.

We perform internal, supplier and mock audits to observe the EN ISO 13485 compliance, provide support during the implementation of resulting actions and temporarily take over the function of the quality management representative.