Risk Management Plan (RMP)
Word template aligned with ISO 14971:2019. Defines the risk management process, scoring scales, acceptability criteria and competence matrix. Sets the framework all other risk documents reference.
Risk Management Documentation Hub
Risk Management Documentation
The audit-ready risk management documentation kit for Regulation (EU) 2017/745 and EN ISO 14971:2019/A11:2021. Cover the full process — from Risk Management Plan to GSPR Checklist — with 6 coordinated templates and active Excel FMEA worksheets that calculate residual risk automatically. Or buy only the template you need.
6 coordinated templates
Active Excel FMEA worksheets
ISO 14971:2019 aligned
Instant download
MD Regulatory
Risk
Risk Management Documentation Kit
6 coordinated templates
Plan · Report · Hazard · FMEAs
ISO 14971 + IEC 62366-1 aligned
Instant download after purchase
Complete Bundle
Risk Management Documentation Kit
Everything you need to build a defensible risk management file under EN ISO 14971:2019/A11:2021 and the EU MDR. 6 professionally drafted templates covering Risk Management Plan, Risk Management Report, Hazard Analysis (with all 46 ISO/TR 24971 Annex A questions), Design FMEA and Use-related FMEA (active Excel worksheets with auto-calculated RPN and region classification) and a complete GSPR Checklist mapping all 159 requirements of MDR Annex I.
4 Word + 3 Excel files
Auto-calc RPN formulas
ISO 14971:2019/A11:2021
ISO/TR 24971:2020
IEC 62366-1 (uFMEA)
MDR Annex I — 159 GSPRs
€349
one-time payment · lifetime access
⚡ Save 16% vs buying templates individually (€414 → €349)
Or buy only the template you need
Each template is professionally drafted, fully editable, and ready to integrate with your technical documentation.
Filter by process phase or reference standard:
Process Phase
Reference Standard
Risk Management Report (RMR)
Word template aligned with ISO 14971:2019. Documents the execution of the RMP, summarises residual risks, performs the overall acceptability assessment and concludes on the benefit-risk balance.
Hazard Analysis (HAN)
Word template implementing the full ISO/TR 24971:2020 Annex A questionnaire to systematically identify hazards across the device lifecycle. Feeds the FMEAs and the Hazard Inventory.
Design FMEA (dFMEA)
Active Excel template with auto-calculated RPN, region classification (Acceptable / AFAP / Unacceptable) and conditional formatting. Includes worked examples and dropdown-driven scoring.
Use-related FMEA (uFMEA)
Active Excel template aligned with IEC 62366-1, focused on use errors and reasonably foreseeable misuse. Includes user profile and use-environment sections, with the same auto-calculated RPN logic of the dFMEA.
GSPR Checklist
Operational Excel checklist covering all 159 General Safety and Performance Requirements of MDR Annex I. Filterable, with applicability dropdown and color-coded compliance status. Standards listed at their latest harmonised editions.
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Aligned with ISO 14971, IEC 62366-1 & EU MDR
Each template is mapped to the relevant harmonised standards, technical reports and MDR articles.
| Template | Primary Reference | Related Guidance | When to produce |
|---|---|---|---|
| RMP | ISO 14971:2019 cl. 4.4 | ISO/TR 24971:2020 | Before design input freeze |
| RMR | ISO 14971:2019 cl. 9 | MDR Art. 61, MDCG 2020-13 | Before NB submission, updated ongoing |
| HAN | ISO/TR 24971:2020 Annex A | ISO 14971 Annex C | Early design phase, refined ongoing |
| dFMEA | ISO 14971:2019 cl. 5 | ISO/TR 24971:2020 | Design verification phase |
| uFMEA | IEC 62366-1:2015/A1:2020 | ISO 14971 cl. 5.5 | Usability engineering process |
| GSPR Checklist | MDR Annex I (all sections) | MDCG 2019-11, 2020-5, 2020-13 | Before NB submission, maintained ongoing |
Frequently Asked Questions
Are these templates ready to submit to a Notified Body?
The templates provide the complete structure, methodology and required content sections expected by Notified Bodies. You must populate them with your device-specific hazards, mitigations, severity / probability / detectability ratings and benefit-risk analysis. They are professional starting points designed to align with NB review expectations — not a substitute for risk management and clinical expertise.
Which MDR risk classes are these templates suitable for?
All six templates are applicable to every MDR class (I, IIa, IIb, III) and to IVDR products with minimal adaptation. The Risk Management Plan and Report follow the ISO 14971:2019 process structure, which is harmonised under both regulations. The GSPR Checklist is MDR-specific (Annex I); a parallel IVDR Annex I version is available separately.
Do the FMEA templates actually compute risk values automatically?
Yes. The Design FMEA and Use-related FMEA are active Excel workbooks with 90 working formulas each. Severity, Probability and Detectability are entered through dropdowns (1-5), then RPN is auto-calculated as S x P x D both pre and post mitigation, and the Region column auto-classifies each hazardous situation as Acceptable, AFAP or Unacceptable using the thresholds defined in the RMP. Conditional formatting applies tricolor visual cues automatically.
How does this kit fit with the EU MDR Clinical Documentation Kit?
The two kits are designed to work together. The Risk Management Report cross-references the Clinical Evaluation Report for benefit-risk conclusions, and the GSPR Checklist references both clinical evidence and risk evidence for each requirement. Customers building a complete Annex II technical file usually purchase both. A combined Risk + Clinical bundle is available at a discounted price.
What format are the files in?
Three Word .docx files (RMP, RMR, HAN) and three Excel .xlsx files (dFMEA, uFMEA, GSPR Checklist), all fully editable. The kit also includes a Master Index spreadsheet with cross-references between templates and a README with usage instructions and update frequency guidance.
Are the standards listed at their latest harmonised editions?
Yes. The kit references EN ISO 14971:2019/A11:2021, EN ISO 13485:2016/A11:2021, EN ISO 10993-1:2020, EN ISO 10993-10:2023, EN ISO 11607-1:2020/A1:2023 and EN IEC 62366-1:2015/A1:2020. The GSPR Checklist also embeds references to the latest MDCG guidance (2019-11, 2019-16, 2020-5, 2020-13).
How do I get updates if standards or MDCG guidance change?
You will receive lifetime access to the kit. When ISO standards are revised, MDCG publishes new guidance or MDR amendments are released, registered customers receive update notifications via email with revised templates at no additional cost.
Is the kit licensed for use across multiple devices?
The kit is licensed for internal use within your organisation across multiple device families and projects. Internal team members can use and adapt the templates. Redistribution outside your organisation or reselling is not permitted.
Do you offer consulting on top of these templates?
Yes. For complex projects (full risk management file drafting, FMEA facilitation workshops, NB audit preparation, GSPR conformity gap analyses) we offer dedicated consulting services. Contact us through the consulting page.