ISO Compliance for Medical Devices

Valicare knows the requirements of the EN ISO 13485

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

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.

  • Quality Risk Management for Medical Devices

    A systematically applied quality risk management ensures the consistent performance of processes and the high quality of products.

    Valicare GmbH supports companies of the medical device industry in the fulfillment of the central requirements of the national and international regulations such as EN ISO 13485, 21 CFR Part 820 with cGMP, GHTF documents or GAMP 5 using the risk-based approach.

    The quality risk management is applied in the general consideration of the criticality of the processes in the QM system. The GMP-compliant qualification of equipment and systems as well as validation to demonstrate the reproducibility of manufacturing processes, cleaning methods, analytical methods and computerized systems is based on a risk-based approach. The criticality determines the depth of the respective test efforts.

    Valicare GmbH offers the customers all commercially available services in this area at the highest professional and technical level.

  • EN ISO 14971 Medical Device Risk Management

    A systematically applied quality risk management ensures the consistent performance of processes and the high quality of products.

    Valicare GmbH supports companies of the medical device industry in the fulfillment of the central requirements of the national and international regulations such as EN ISO 13485, 21 CFR Part 820 with cGMP, GHTF documents or GAMP 5 using the risk-based approach.

    The quality risk management is applied in the general consideration of the criticality of the processes in the QM system. The GMP-compliant qualification of equipment and systems as well as validation to demonstrate the reproducibility of manufacturing processes, cleaning methods, analytical methods and computerized systems is based on a risk-based approach. The criticality determines the depth of the respective test efforts.

    Valicare GmbH offers the customers all commercially available services in this area at the highest professional and technical level.

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Contact us if you have any questions. We will gladly answer and advise you.