Risk Management Documentation Kit – MDR
€349.00
ISO 13485 & MDSAP Ready
Editable Word & Excel
ISO 13485 / MDSAP / FDA QMSR
Used by 100+ quality teams
EN ISO 14971:2019/A11:2021 · IEC 62366-1 · EU MDR Annex I
Risk Management Documentation Kit — EU MDR
Six coordinated templates that carry a device from the risk management plan to a completed GSPR checklist, built to be filed together, not assembled from six separate starting points.
Six templates that do not talk to each other
A risk management plan states a process. A hazard analysis lists hazards. A design FMEA scores them. A use FMEA scores different ones, from a different questionnaire, in a different tool. By the time the GSPR checklist is filled in, nothing in it traces back to the file that was supposed to support it — because the six documents were never built to reference one another in the first place.
The fix is not a better risk management plan. It is a file where the hazard analysis, both FMEAs and the GSPR checklist share one hazard list and one set of identifiers, so a reviewer can follow a single risk from identification to residual acceptability without switching vocabulary.
None of this is difficult. It is the consequence of buying six templates instead of one coordinated file.
- 3 Word documents
- 4 Excel workbooks
- Single ZIP
- Instant download
- Fully editable
- Master index included
Scope
What the kit covers
The full risk management file required by EN ISO 14971, cross-referenced to IEC 62366-1 for use-related risk and to MDR Annex I for the requirements the file has to demonstrate.
01
Plan and report
The Risk Management Plan, aligned with clause 4.4, and the Risk Management Report, aligned with clause 9 — the two documents that open and close the file.
02
Hazard identification and analysis
A Hazard Analysis built on the full ISO/TR 24971 Annex A questionnaire, 46 questions, feeding a single hazard list that both FMEAs reuse.
03
FMEA and GSPR conformity
A Design FMEA with auto-calculated Risk Priority Number, a Use-related FMEA aligned with IEC 62366-1, and a GSPR Checklist covering all 159 requirements of MDR Annex I.
Contents
What is in the ZIP
Audience
Who the kit is for
- Regulatory affairs and quality managers assembling an MDR technical file
- Manufacturers with no risk management file to start from
- Consultants who need a coordinated file rather than six separate templates
- PRRC and quality managers reviewing a file before submission
The kit assumes you know your device’s intended use and classification. It does not teach ISO 14971: it gives you the file the standard requires, already cross-referenced, ready to complete with your own device data.
What is included
What you get when you buy
- 3 Microsoft Word documents, fully editable
- 4 Microsoft Excel workbooks, fully editable
- A master index spreadsheet linking all six files
- A README with usage instructions
- Delivered as a single ZIP, instant download after purchase
Questions
Before you buy
Do the six files actually reference each other?
Yes. The Hazard Analysis produces one hazard list with fixed identifiers; both FMEAs and the GSPR checklist reuse those identifiers, so a hazard can be traced from identification to residual risk acceptability across the file.
Do I need a copy of ISO 14971 or IEC 62366-1?
No. Each template quotes the clause it implements. You will still want the standards themselves for anything the template references but does not reproduce.
Can I buy the templates individually instead?
Yes, each of the six is also sold on its own. The kit is priced below buying all six separately and adds the master index and README that only ship with the kit.
What software do I need?
Microsoft Word and Excel, or a compatible alternative that opens .docx and .xlsx files without reflowing tables.
Is this a one-off purchase?
Yes. The licence is for single-organisation use and the files are yours to keep, with no recurring cost.
Does the GSPR checklist cover the full Annex I?
Yes, all 159 requirements, each with space to record applicability, method of conformity and evidence reference.
Can I use this kit for an IVDR device?
No. This kit is built against MDR Annex I and EN ISO 14971 under the MDR route. IVDR devices need the equivalent IVDR risk management kit, cross-referenced to IVDR Annex I instead.
Can my company buy several licences?
Yes. Contact us before purchasing and we will arrange it under one invoice.
Risk and clinical, together
Add the clinical documentation kit and file both at once.
Combine this kit with the EU MDR Clinical Documentation Kit in the Risk + Clinical Documentation Bundle for €599 against €748 bought separately.
Risk Management Documentation Kit — EU MDR
Six coordinated templates, one ZIP, instant download.
€349.00
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