Use-related FMEA (uFMEA) Template – MDR
€69.00
ISO 13485 & MDSAP Ready
Editable Word & Excel
ISO 13485 / MDSAP / FDA QMSR
Used by 100+ quality teams
EN IEC 62366-1:2015/A1:2020
Use-related FMEA (uFMEA) Template — EU MDR
The bridge between usability engineering and the risk file: an active Excel workbook scoring slips, lapses, mistakes and foreseeable misuse against the same calculation engine as the design FMEA.
€69
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Excel .xlsx · 90 formulas · README included
Instant download
Use error risk gets scored against the wrong scale
A design FMEA scores what happens if a component fails. A use error — a slip, a lapse, a mistake, a reasonably foreseeable misuse — is a different kind of event, and scoring it on a design-oriented scale misses the point: the device performed exactly as specified, and harm still occurred because of how it was used.
IEC 62366-1 gives use error its own vocabulary. A use FMEA that keeps that vocabulary, and calculates its RPN the same way the design FMEA does, is what lets the two feed one Risk Management Report without a translation step in between.
None of this is difficult. It is the consequence of treating use error as a variant of design failure instead of its own category.
- Excel .xlsx
- 8 worksheets
- 90 formulas
- Auto-calculated RPN
- 3 worked examples
- Instant download
Scope
What the template covers
The complete Use-related FMEA structure aligned with IEC 62366-1, from use error typing to the region classification a reviewer reads first.
01
Use error typing
A Use Error Type dropdown — Slip, Lapse, Mistake, Reasonably Foreseeable Misuse — applied consistently across every scenario.
02
Scoring and calculation
Auto-calculated RPN with Region classification and conditional formatting, on the same scale as the Design FMEA.
03
Structure and examples
24 columns covering use scenario, task, use error, consequences, root causes and risk controls, with three worked examples: misconnection, setting error, foreseeable reuse.
Contents
What the workbook contains
Audience
Who the template is for
- Regulatory affairs and quality managers scoring use-related risk
- Manufacturers running usability engineering under IEC 62366-1 alongside ISO 14971
- Consultants who need use error scored on its own vocabulary, not a design scale
The template assumes a usability engineering process is already identifying use scenarios and use errors, or is being built alongside it. It does not teach IEC 62366-1: it gives you a working calculation engine, ready for your own scores.
What is included
What you get when you buy
- 1 Microsoft Excel .xlsx file, fully editable
- Compatible with Excel 2016+ or LibreOffice Calc
- A slim README with usage instructions
- Delivered as a small ZIP, instant download after purchase
Questions
Before you buy
Does the RPN calculate automatically?
Yes, on the same scale and formula structure as the Design FMEA, so the two can feed one Risk Management Report without conversion.
Can I import the hazard list from the Hazard Analysis template?
The Hazard Inventory worksheet is built to receive it. If you use both templates from the Risk Management Documentation Kit, the identifiers are already aligned.
Is this the whole risk file?
No. This is one of six coordinated documents. It scores use-related risk identified during usability engineering.
Can I buy the full kit instead?
Yes. This template is one of six in the Risk Management Documentation Kit, priced at €349 against €414 buying all six separately.
What software do I need?
Microsoft Excel 2016 or later, or LibreOffice Calc.
Is this a one-off purchase?
Yes. The licence is for single-organisation use and the file is yours to keep.
Need the full risk file?
This template is one of six in the coordinated kit.
The Risk Management Documentation Kit ships this workbook alongside the Risk Management Plan, Report, Hazard Analysis and the Design FMEA, all built on one shared hazard list. €349 against €414 buying the six separately.
Use-related FMEA (uFMEA) Template — EU MDR
One Excel workbook, 90 formulas, use error scored on its own terms.
€69.00
