Risk management remains a key document in technical documentation. Use the phase of preparation for MDR and critically review your risk management process once again. This not only ensures that the risks of your medical device are identified, controllable and in appropriate balance to the benefit. You can also benefit from the identification of valuable indicators for monitoring trends. Because this not only requires an up-to-date quality management, but also ensures the long-term success of your company.
We support you:
- Review of your existing risk management system.
- Preparation or revision of your risk management plan.
- Performing the risk analysis and preparing the risk management report.
- Establish and maintenance of a risk management file.
Documentation in English language, optionally in German language.