Risk Management Documentation Kit – MDR

Risk Management Documentation Kit — EU MDR

What it is: the complete risk management documentation file aligned with EN ISO 14971:2019/A11:2021, IEC 62366-1 and EU MDR Annex I. Six coordinated templates that work together: from defining the risk process to demonstrating conformity to the General Safety and Performance Requirements.

What is included

• Risk Management Plan — Word document, aligned with ISO 14971 clause 4.4
• Risk Management Report — Word document, aligned with ISO 14971 clause 9
• Hazard Analysis — Word document implementing the full ISO/TR 24971 Annex A questionnaire (46 questions)
• Design Failure Mode and Effects Analysis — Excel workbook with auto-calculated Risk Priority Number
• Use-related Failure Mode and Effects Analysis — Excel workbook aligned with IEC 62366-1
• General Safety and Performance Requirements Checklist — Excel workbook covering all 159 requirements of MDR Annex I
• Master Index spreadsheet + README with usage instructions

Format

3 Microsoft Word documents + 4 Microsoft Excel workbooks (fully editable). Delivered as a single ZIP. Instant download after purchase.

Need clinical documentation too?

Combine this kit with the EU MDR Clinical Documentation Kit in the Risk + Clinical Bundle and save an additional 20%: EUR 599 vs EUR 748 buying separately.