Risk + Clinical Documentation Bundle – MDR
€599.00
ISO 13485 & MDSAP Ready
Editable Word & Excel
ISO 13485 / MDSAP / FDA QMSR
Used by 100+ quality teams
EU MDR · ISO 14971 · Annex XIV
Risk + Clinical Documentation Bundle — EU MDR
Fourteen templates, cross-referenced to each other, for the two parts of the technical file most Notified Body submissions require together.
Risk and clinical evidence are filed as two unrelated stories
A Notified Body reviewer reads the benefit-risk conclusion in the Risk Management Report and the clinical evidence in the Clinical Evaluation Report, and expects the two to agree on the same residual risks and the same acceptability criteria. When the two files were built independently, they usually do not: the GSPR checklist ends up citing risk evidence in one place and clinical evidence in another, with no reference between them.
Buying the two kits as one coordinated bundle means the Risk Management Report cross-references the Clinical Evaluation Report for the benefit-risk conclusion, and the GSPR checklist points to both, instead of treating them as separate exercises that happen to share a device.
None of this is difficult. It is the consequence of building the two files at different times, for different reasons.
- 14 templates
- 7 Word documents
- 7 Excel workbooks
- 2 master indexes
- 2 ZIP archives
- Instant download
Scope
What the bundle covers
The full risk management file and the full clinical evidence file, cross-referenced for Risk ↔ Clinical traceability throughout.
01
Risk Management Documentation Kit
Six templates: Plan, Report, Hazard Analysis, Design FMEA, Use FMEA and the GSPR Checklist, built on one shared hazard list.
02
EU MDR Clinical Documentation Kit
Eight templates covering the clinical evaluation, development, post-market surveillance and follow-up documents required by Annex XIV.
03
Cross-kit traceability
The Risk Management Report references the Clinical Evaluation Report’s benefit-risk conclusions, and the GSPR checklist cites evidence from both kits by ID.
Contents
The 14 templates
Audience
Who the bundle is for
- Regulatory affairs managers preparing a full Notified Body submission
- Manufacturers who need risk and clinical evidence to reference each other
- Consultants assembling both files for the same technical documentation
- Quality managers who need the GSPR checklist to cite verifiable evidence
The bundle assumes you know your device’s intended use, classification and clinical background. It does not teach ISO 14971 or the clinical evaluation process: it gives you the fourteen documents already cross-referenced, ready to complete with your own device data.
What is included
What you get when you buy
- 7 Microsoft Word documents, fully editable
- 7 Microsoft Excel workbooks, fully editable
- 2 master index spreadsheets, one per kit
- 2 READMEs with cross-references between the two kits
- Delivered as two ZIP archives, instant download after purchase
Questions
Before you buy
How much do I save against buying the two kits separately?
Buying the two kits separately costs €748 (€349 + €399). The bundle is €599, a saving of €149, or 20%.
Do the two kits actually reference each other?
Yes. The Risk Management Report cross-references the Clinical Evaluation Report’s benefit-risk conclusions, and the GSPR Checklist cites evidence IDs from both kits.
Can I buy just one of the two kits?
Yes. The Risk Management Documentation Kit and the EU MDR Clinical Documentation Kit are each sold separately, without the cross-kit references.
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 this include the rest of the technical file?
No. Device description, labelling and V&V documentation are covered by the EU MDR Technical Documentation Kit, sold separately or in the MDR Complete Bundle.
Can I use this for an IVDR device?
No. This bundle is built against MDR Annex I, Annex XIV and Article 61. IVDR devices need the equivalent IVDR risk and performance evaluation kits.
Can my company buy several licences?
Yes. Contact us before purchasing and we will arrange it under one invoice.
Need the rest of the technical file?
The MDR Complete Bundle adds device description, labelling and V&V.
Combine this bundle with the EU MDR Technical Documentation Kit in the MDR Complete Bundle and save 15%: €999 against €1,177 buying separately.
Risk + Clinical Documentation Bundle — EU MDR
14 templates, cross-referenced, two ZIP archives, instant download.
€599.00
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