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
EN ISO 14971:2019/A11:2021 · Clause 4.4
Risk Management Plan (RMP) Template — EU MDR
The document that sets the framework every other risk file references — scoring scales, matrix and thresholds already built, ready to fill with your device data.
The plan gets written after the risk file, not before it
Clause 4.4 asks for a plan that sets the process before the hazard analysis and the FMEAs start scoring anything. In practice the plan is often drafted last, to describe what the team already did — which means the scoring scales, the matrix and the acceptability thresholds in the plan do not match the ones actually used in the file it is supposed to govern.
The plan has to fix the scales, the matrix and the thresholds once, in a document every other risk document then cites. Written afterwards, it can only describe; written first, it constrains.
Neither is a hard document to write. What is hard is writing it before the scoring has already happened informally.
- Word .docx
- Fully editable
- README included
- Instant download
- Single document
Scope
What the template covers
Every element clause 4.4 requires, structured so the Risk Management Report and both FMEAs can reference it directly.
01
Process and scope
Risk management process scope, responsibilities and how the process integrates with the product lifecycle, from design through post-market.
02
Scoring and matrix
Severity, Probability and Detectability scales (1-5) with clinical descriptors, a colour-coded 5×5 risk matrix, and RPN acceptability thresholds — Acceptable, AFAP, Unacceptable.
03
Controls and review
Risk control option analysis criteria per clause 7.1, the post-market surveillance feedback loop and trigger criteria for risk file updates, and the risk management review process with a competence matrix.
Contents
What the document contains
Audience
Who the template is for
- Regulatory affairs and quality managers starting a risk file from nothing
- Manufacturers whose current plan does not match the scales used in the rest of the file
- Consultants who need a plan that other documents can cite by clause and section
The template assumes you know your device’s intended use. It does not teach ISO 14971: it gives you a plan already structured to clause 4.4, ready to complete with your organisation’s own responsibilities and thresholds.
What is included
What you get when you buy
- 1 Microsoft Word .docx file, fully editable
- A slim README with usage instructions
- Delivered as a small ZIP, instant download after purchase
Questions
Before you buy
Do I need ISO 14971 to use this?
No. The template quotes the clause it implements throughout. You will still want the standard itself for anything it references but does not reproduce.
Will the scales in this template match my existing FMEA?
Only if your FMEA uses the same 1-5 scales. The Risk Management Documentation Kit ships all six documents built against the same scales from the start, which avoids this mismatch entirely.
Is this the whole risk file?
No. This is one of six coordinated documents. On its own it sets the framework; the Hazard Analysis, both FMEAs, the Risk Management Report and the GSPR Checklist complete the file.
Can I buy the full kit instead?
Yes. This template is one of six in the Risk Management Documentation Kit, priced at €349 against €414 buying all six separately.
What software do I need?
Microsoft Word, or a compatible alternative that opens .docx files without reflowing tables.
Is this a one-off purchase?
Yes. The licence is for single-organisation use and the file is yours to keep.
Need the full risk file?
This template is one of six in the coordinated kit.
The Risk Management Documentation Kit ships this plan alongside the Risk Management Report, Hazard Analysis and both FMEAs, all built on one shared hazard list. €349 against €414 buying the six separately.
Risk Management Plan (RMP) Template — EU MDR
One Word document, the framework the rest of the risk file references.
€69.00
