Design FMEA (dFMEA) Template – MDR
€69.00
ISO 13485 & MDSAP Ready
Editable Word & Excel
ISO 13485 / MDSAP / FDA QMSR
Used by 100+ quality teams
EN ISO 14971:2019/A11:2021
Design FMEA (dFMEA) Template — EU MDR
An active Excel workbook that calculates the Risk Priority Number for you, so the team spends its time identifying failure modes, not building formulas.
€69
VAT calculated at checkout
Excel .xlsx · 90 formulas · README included
Instant download
The RPN is calculated by hand, differently each time
A design FMEA built in a blank spreadsheet gets its Risk Priority Number typed in manually, column by column, row by row. Different people round differently, the pre- and post-mitigation scores drift out of formula, and the colour coding that is supposed to flag the unacceptable region is applied by eye instead of by rule.
An FMEA that scores 40 or 60 failure modes needs the arithmetic to be automatic and consistent, so the team’s attention goes to identifying failure modes and controls, not to checking multiplication.
None of this is difficult. It is the difference between a spreadsheet and a working template.
- Excel .xlsx
- 7 worksheets
- 90 formulas
- Auto-calculated RPN
- 3 worked examples
- Instant download
Scope
What the template covers
The complete Design FMEA structure aligned with ISO 14971, from scoring to the region classification a reviewer reads first.
01
Scoring and calculation
Severity, Probability and Detectability dropdowns (1-5), with the RPN auto-calculated (S × P × D) both pre- and post-mitigation.
02
Region classification
Automatic Region classification with conditional tricolor formatting, so the unacceptable rows are visible without a manual review pass.
03
Structure and examples
23 columns covering function, failure mode, effects, causes, controls and verification, with three worked examples: biocompatibility, structural, thermal.
Contents
What the workbook contains
Audience
Who the template is for
- Regulatory affairs and quality managers scoring design-related risks
- Manufacturers whose current FMEA calculates RPN by hand
- Consultants who need a workbook that flags unacceptable regions automatically
The template assumes you know your device’s design and failure modes, or are identifying them alongside the Hazard Analysis. It does not teach ISO 14971: 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. Severity, Probability and Detectability are entered from dropdowns; the workbook calculates the RPN and applies the region classification with conditional formatting.
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 design-related risks identified in the Hazard Analysis.
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 Use FMEA, all built on one shared hazard list. €349 against €414 buying the six separately.
Design FMEA (dFMEA) Template — EU MDR
One Excel workbook, 90 formulas, the RPN calculated for you.
€69.00
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