Risk Management Report (RMR) Template – MDR
€69.00
ISO 13485 & MDSAP Ready
Editable Word & Excel
ISO 13485 / MDSAP / FDA QMSR
Used by 100+ quality teams
Risk Management Report (RMR) Template — EU MDR
What it is: a professionally drafted Word template for the Risk Management Report required by EN ISO 14971:2019/A11:2021, clause 9. The RMR closes the risk management process: it documents that the RMP has been executed, that all residual risks are acceptable and that the benefit-risk balance supports placing the device on the market.
What is included
- Executive summary and conclusion structure expected by Notified Bodies
- Reference to RMP and traceability to all risk inputs (HAN, dFMEA, uFMEA, post-market data)
- Pre/post mitigation risk distribution table
- 7-criterion overall residual risk acceptability assessment
- Benefit-risk analysis structured per Article 61 MDR
- PMS data review section and risk file change history
Format
1 Microsoft Word .docx file (fully editable) + slim README with usage instructions. Delivered as a small ZIP. Instant download after purchase.
Need the full risk file?
This is 1 of 6 templates in the Risk Management Documentation Kit. Save 16% with the bundle: EUR 349 vs EUR 414 buying individually.
€69.00
