Risk Management Plan for Medical Devices

The foundation of any compliant ISO 14971 file is the Risk Management Plan (RMP). It must define the scope of the risk management activities, the lifecycle phases, roles and responsibilities, and the specific criteria for risk acceptability.

MedMI simplifies the creation of your RMP. Based on the device profile you enter, the platform helps establish appropriate probability and severity scales and sets the baseline for your Risk Acceptability Matrix.

With a structured plan in place, the subsequent hazard generation and risk evaluation phases flow seamlessly, ensuring end-to-end traceability and compliance.