Risk Management Plan (RMP) Template – MDR
€69.00
ISO 13485 & MDSAP Ready
Editable Word & Excel
ISO 13485 / MDSAP / FDA QMSR
Used by 100+ quality teams
Risk Management Plan (RMP) Template — EU MDR
What it is: a professionally drafted Word template for the Risk Management Plan required by EN ISO 14971:2019/A11:2021, clause 4.4. The RMP is the cornerstone of the risk file: it sets the framework all other risk documents reference.
What is included
- Risk management process scope, responsibilities and lifecycle integration
- Severity, Probability and Detectability scoring scales (1-5) with clinical descriptors
- Colored 5×5 risk matrix and RPN acceptability thresholds (Acceptable / AFAP / Unacceptable)
- Risk control option analysis criteria per ISO 14971 cl. 7.1
- Post-Market Surveillance feedback loop and trigger criteria for risk file updates
- Risk Management Review process and competence matrix
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
Alessandro Stella
Alessandro Stella is a freelance Medical Device Regulatory Consultant and ISO 13485 / ISO 9001 Lead Auditor based in Italy. With over 13 years of experience spanning R&D, Quality, and Regulatory Affairs, he has supported companies across Europe and beyond in EU MDR technical documentation, QMS implementation, ISO 13485 compliance, and FDA submissions. His device expertise covers cardiovascular devices, AI-based standalone software, robotic surgery systems, active wearables, and more. Alessandro is the founder of MD Regulatory.