Usability Engineering — Process Package (ISO 13485)
€69.00
ISO 13485 & MDSAP Ready
Editable Word & Excel
ISO 13485 / MDSAP / FDA QMSR
Used by 100+ quality teams
Process Package
Complete usability engineering system covering IEC 62366-1:2015 + AMD1:2020, FDA HFE Guidance 2016, EU MDR Annex I §5. Use Specification + URRA + Formative + Summative evaluation framework.
What’s included:
- SOP-ISO-29 Usability Engineering — full UE process from Use Specification through Summative Evaluation.
- F-ISO-29.1 Use Specification & Use Error Analysis (Word) — combined Part A (Use Spec IEC 62366-1 §5.3) + Part B (URRA §5.4): 8 task categories, P/C/A use error classification, mitigation hierarchy ISO 14971 §7.
- F-ISO-29.2 UEF Summary (Word) — index of 9 IEC 62366-1 deliverables (§5.3-5.10), Summative Evaluation summary (15+ participants per FDA), residual use-related risks.
Why this package: Use error is a leading cause of medical device adverse events. This package gives you the IEC 62366-1 framework with FDA HFE 2016 alignment for any device with user interaction.
Format: Microsoft Word (fully editable)
Updated: May 2026 — reflects EU MDR + FDA QMSR (Feb 2026) + latest MDCG guidance
Delivery: Instant download after purchase
€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.