Hazard Analysis (HAN) Template – MDR
€69.00
ISO 13485 & MDSAP Ready
Editable Word & Excel
ISO 13485 / MDSAP / FDA QMSR
Used by 100+ quality teams
Hazard Analysis (HAN) Template — EU MDR
What it is: a professionally drafted Word template implementing the complete questionnaire of EN ISO/TR 24971:2020 Annex A. The Hazard Analysis is the systematic input to the risk file: it forces the team to consider every possible source of harm before the FMEAs prioritise them.
What is included
- All 46 questions of ISO/TR 24971:2020 Annex A, with pre-populated factors-to-consider
- A.2.31.1-9 sub-questions on materials and chemical characterisation
- 5 hazard categories per ISO 14971:2019 Annex C (energy, biological, chemical, operational, information)
- Structured Hazard Inventory section with traceability to FMEAs
- Lifecycle phase coverage (manufacturing, transport, storage, use, maintenance, disposal)
- Foreseeable misuse scenarios placeholder
Format
1 Microsoft Word .docx file (fully editable) + 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
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.