Design FMEA (dFMEA) Template - MDR

Design FMEA (dFMEA) Template – MDR

€69.00

SKU DFMEA-MDR-001 Categories , Tags , , ,

ISO 13485 & MDSAP Ready

Editable Word & Excel

ISO 13485 / MDSAP / FDA QMSR

Used by 100+ quality teams

Design FMEA (dFMEA) Template — EU MDR

What it is: an active Excel template for the Design FMEA aligned with EN ISO 14971:2019/A11:2021. The dFMEA is where the team quantifies and prioritises the design-related risks identified in the Hazard Analysis. This template does the math for you — you focus on identifying failure modes and assigning the scores.

What is included

  • 7 worksheets: Cover, Instructions, Scales, Hazard Inventory, dFMEA, Risk Matrix, Acronyms
  • 90 working formulas pre-populated
  • Severity, Probability, Detectability dropdowns (1-5)
  • Auto-calculated RPN (S x P x D) pre and post mitigation
  • Automatic Region classification with conditional tricolor formatting
  • 23 columns covering function, failure mode, effects, causes, controls and verification
  • 3 worked examples: biocompatibility, structural, thermal

Format

1 Microsoft Excel .xlsx file (fully editable, Excel 2016+ or LibreOffice Calc compatible) + slim README with usage instructions. Delivered as a small ZIP. Instant download after purchase.

Need the full risk file?

This is 1 of 6 templates in the Risk Management Documentation Kit. Save 16% with the bundle: EUR 349 vs EUR 414 buying individually.

€69.00

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Alessandro Stella

Alessandro Stella is a freelance Medical Device Regulatory Consultant and ISO 13485 / ISO 9001 Lead Auditor based in Italy. With over 13 years of experience spanning R&D, Quality, and Regulatory Affairs, he has supported companies across Europe and beyond in EU MDR technical documentation, QMS implementation, ISO 13485 compliance, and FDA submissions. His device expertise covers cardiovascular devices, AI-based standalone software, robotic surgery systems, active wearables, and more. Alessandro is the founder of MD Regulatory.