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EN ISO 13485 Compliance for Medical Devices

  • A woman with a syringe
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    Compliance with the EN ISO 13485 norm is mandatory for the medical device manufacturing industry.

    We support you in implementing the required measures. Call us on +49 69 7909 343.

  • prefilled syringes
    next page

    Compliance with the EN ISO 13485 norm is mandatory for the medical device manufacturing industry.

    We support you in implementing the required measures. Call us on +49 69 7909 343.

 
Content

Valicare knows the requirements of the EN ISO 13485

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

Valicare GmbH supports customers in ensuring that management processes are in compliance with this norm.

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 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 we take over the function of the quality management representative.