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.

On the basis of GAP/target/actual analyses (audits), we determine compliance with the standard and support you in implementing the resulting measures.

The update and implementation of QM systems in relation to the requirements of the revision ISO 13485:2016 is implemented through conceptual work and the creation of documents. In doing so, we apply risk-based considerations to all business processes.

The preparation of the design documents and the development file according to ISO 13485 7.3 and FDA Design Control 21 CFR 820.30 is also part of our service portfolio.

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

This also includes the qualification of equipment and facilities. Here we know exactly what is important and what is necessary and indispensable. Our motto is "As little as possible but as much as necessary" and guarantees you an efficient approach.

We support you in the practical implementation of the concept, with the aim of providing objective proof that your product meets all regulatory and customer requirements.

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

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

  • 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

    Risk management according to EN ISO 14971 represents an essential part of quality assurance in the medical device manufacturing industry. The implementation and systematic application of the norm specifications enables the companies to eliminate or minimize the risks of their medical devices through conceptual or constructive measures.

    Valicare GmbH offers the following services for this purpose:

    • Development of a risk management concept SOP for to implementation of the norm specifications
    • Support in the implementation of risk analysis, risk assessment and risk control using, for example, an FMEA ("Failure Mode and Effective Analysis"), by preparing plans and creating and moderating the FMEA
    • Introduction of tools for monitoring the effectiveness of the measures introduced
    • Supporting or preparing the risk management report and building a risk matrix
    • Implementation of processes to integrate information from production and downstream phases into the risk management process
    • Support in setting up and maintaining the risk management file
    • Training on risk management and its implementation in the company

    Benefit from our long-term experience and expertise in the field of risk management.

We are there for you

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