Hazard Analysis (HAN) Template – MDR
€69.00
ISO 13485 & MDSAP Ready
Editable Word & Excel
ISO 13485 / MDSAP / FDA QMSR
Used by 100+ quality teams
EN ISO/TR 24971:2020 Annex A · ISO 14971:2019 Annex C
Hazard Analysis (HAN) Template — EU MDR
The full 46-question Annex A questionnaire, structured into a hazard inventory both FMEAs can reuse without re-deriving the hazard list.
The questionnaire gets answered, the hazard list gets rebuilt
Annex A of ISO/TR 24971 exists so a team does not rely on memory to find every source of harm: 46 questions, run once, produce a structured hazard inventory. What often happens instead is the questionnaire gets worked through as an exercise, and then the Design FMEA and Use FMEA each build their own hazard list from scratch — two different lists, from two different starting points, for the same device.
A hazard analysis only pays for itself if its output is the input both FMEAs actually use, with the same identifiers, so a hazard traced in one shows up in the other.
None of this is difficult. It is the consequence of treating the questionnaire as paperwork rather than as the source document it is meant to be.
- Word .docx
- Fully editable
- README included
- Instant download
- Single document
Scope
What the template covers
The complete Annex A questionnaire, plus the categorisation and lifecycle structure that turns its answers into a usable hazard inventory.
01
The full Annex A questionnaire
All 46 questions with pre-populated factors-to-consider, including the A.2.31.1-9 sub-questions on materials and chemical characterisation.
02
Hazard categorisation
The five hazard categories of ISO 14971:2019 Annex C — energy, biological, chemical, operational, information — applied consistently across the inventory.
03
Lifecycle and inventory
Coverage across manufacturing, transport, storage, use, maintenance and disposal, with a structured Hazard Inventory section built for direct FMEA traceability, plus a foreseeable misuse scenarios placeholder.
Contents
What the document contains
Audience
Who the template is for
- Regulatory affairs and quality managers running the hazard identification step
- Manufacturers whose FMEAs currently use inconsistent hazard lists
- Consultants who need a single hazard inventory both FMEAs can reference
The template assumes you know your device’s intended use and lifecycle. It does not teach ISO 14971 or ISO/TR 24971: it gives you the questionnaire already structured to feed the rest of the risk file.
What is included
What you get when you buy
- 1 Microsoft Word .docx file, fully editable
- A slim README with usage instructions
- Delivered as a small ZIP, instant download after purchase
Questions
Before you buy
Do I need ISO/TR 24971 to use this?
No. Every question is reproduced in full inside the template. You will still want the technical report itself for the surrounding guidance it gives on each question.
Will the hazard list here match my FMEAs?
Only if your FMEAs are built to reuse this inventory’s identifiers. The Risk Management Documentation Kit ships all six documents sharing one hazard list from the start.
Is this the whole risk file?
No. This is one of six coordinated documents. It feeds the Design FMEA, Use FMEA and, through them, the Risk Management Report.
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 Word, or a compatible alternative that opens .docx files without reflowing tables.
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 analysis alongside the Risk Management Plan, Risk Management Report and both FMEAs, all built on one shared hazard list. €349 against €414 buying the six separately.
Hazard Analysis (HAN) Template — EU MDR
One Word document, 46 questions, one hazard inventory both FMEAs can share.
€69.00
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