Risk Management Services
Both the medical device regulation and different harmonized standards require a risk management process. EN ISO 14971 describes a process for the application of risk management to medical devices. The standard offers a procedure enabling the manufacturer to identify, assess, and control the risks linked to its medical device.
Our Services Relating to EN ISO 14971
- Organizing workshops and seminars to train your team: Tailored exactly to your needs, we discuss your individual questions together.
- Moderating risk analyses: Your team has the product-specific expertise, we take care of the timely implementation of risk analysis.
- Developing and optimizing the risk management process: Risk management is a central component of your quality management system. We take care that the process is efficiently integrated into your system.
- Integrating the risk management results into the technical documentation: We ensure that the risk management is appropriately linked to the other parts of your technical documentation.
- Verifying risk management measures: For your risk management measures you do not only have to prove that they have been implemented properly, but also that they are effective. We are happy to support you in planning and implementing your verification measures.
Our risk management file services
Preparing the risk management file consisting of:
- Risk management plan,
- Preparation and moderation of risk analyses,
- Risk assessment and development of risk-reducing measures,
- Verification of measures, their effectiveness and traceability,
- Risk management report.
- Assessing existing risk management files against current standard requirements and implementing new requirements.
- Identifying and analyzing non-conformities in risk management and developing possible improvements in the scope of the existing QM system.
- Adapting the risk analysis throughout the entire product lifecycle.
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