Scope & Lifecycle
A robust Risk Management Plan (RMP) is the foundation of your ISO 14971 compliance. Without it, your Risk Analysis has no anchor.
Roles & Responsibilities
Your template must explicitly define the scope of the device and the phases of the lifecycle it covers (e.g., from design input to post-market surveillance).
Risk Acceptability Criteria
One of the most heavily audited sections of the RMP is the Risk Acceptability Matrix. You must define what constitutes a "Broadly Acceptable", "ALARP", or "Unacceptable" risk. Do not simply copy generic 5x5 matrices; ensure the scales fit the clinical reality of your device.
Traceability Requirements
Finally, define how risk controls will be verified and traced. This is where MedMI excels, automating the traceability between your RMP, Hazard Analysis, and Verification testing.