Use-related FMEA (uFMEA) Template - MDR

Use-related FMEA (uFMEA) Template – MDR

€69.00

SKU UFMEA-MDR-001 Categories , Tags , , ,

ISO 13485 & MDSAP Ready

Editable Word & Excel

ISO 13485 / MDSAP / FDA QMSR

Used by 100+ quality teams

Use-related FMEA (uFMEA) Template — EU MDR

What it is: an active Excel template for the Use-related FMEA aligned with EN IEC 62366-1:2015/A1:2020. The uFMEA addresses risks that originate not from the design but from how the user interacts with the device: slips, lapses, mistakes and reasonably foreseeable misuse. It bridges the usability engineering process and the overall risk management file.

What is included

  • 8 worksheets: Cover, Instructions, Scales, User Profiles & Use Environments, Hazard Inventory, uFMEA, Risk Matrix, Acronyms
  • 90 working formulas pre-populated
  • Use Error Type dropdown (Slip / Lapse / Mistake / Reasonably Foreseeable Misuse)
  • Auto-calculated RPN with Region classification and conditional formatting
  • 24 columns covering use scenario, task, use error, consequences, root causes, risk controls
  • 3 worked examples: misconnection, setting error, foreseeable reuse

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.