Risk + Clinical Documentation Bundle – MDR

Risk + Clinical Documentation Bundle — EU MDR

What it is: two coordinated kits 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 and risk evidence for each requirement. Manufacturers preparing a full Notified Body submission usually need both.

What is included

Risk Management Documentation Kit — 6 templates:

• Risk Management Plan
• Risk Management Report
• Hazard Analysis
• Design Failure Mode and Effects Analysis
• Use-related Failure Mode and Effects Analysis
• General Safety and Performance Requirements Checklist

EU MDR Clinical Documentation Kit — 8 templates:

• Clinical Evaluation Plan
• Clinical Evaluation Report
• Clinical Development Plan
• Post-Market Surveillance Plan
• Periodic Safety Update Report
• Post-Market Clinical Follow-up Plan
• Post-Market Clinical Follow-up Evaluation Report
• Summary of Safety and Clinical Performance

14 templates in total: 7 Word documents + 7 Excel workbooks, plus 2 Master Index spreadsheets and 2 READMEs (one per kit) with cross-references between the two kits for full Risk ↔ Clinical traceability.

Format

14 fully editable Microsoft Word and Excel files. Delivered as two ZIP archives (one per kit). Instant download after purchase.

What you save

Buying the two kits separately costs EUR 748 (EUR 349 + EUR 399). The combined bundle is EUR 599 — you save EUR 149 (20%).