Compliance with DIN EN ISO 13485 for manufacturers of medical devices

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

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

Quality risk management is applied in the general consideration of the criticality of 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's services in this area are at the highest professional and technical level.

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 companies to eliminate or minimize the risks of their medical devices through conceptual or constructive measures.

Valicare offers the following services and support for this purpose:

• Development of a risk management concept
• SOP for the implementation of norm specifications
• Implementation of risk analysis, risk assessment, and risk control using, e.g., an FMEA (Failure Mode and Effects Analysis), preparing plans, creating and moderating the FMEA
• Introduction of tools to monitor the effectiveness of the measures introduced

• Risk management report and preparing a risk matrix
• Implementation of processes to integrate information from production and downstream phases into the risk management process
• 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 risk management.