IEC 62366-1 Usability Engineering Mandatory Documents Kit
IEC 62366-1:2015 defines the usability engineering process for medical devices. This kit contains the 9 core documents needed to build and evidence a complete usability engineering file.
Usability Engineering Plan
Template document
Usability Engineering File Index
Template document
What's included
Everything you need to build a complete compliance documentation set.
- Usability Engineering Plan
- Usability Engineering File Index
- Use Specification (Intended Use, User Groups, Use Environment)
- User Interface Characteristics Specification
- Use-Related Risk Analysis (URRA)
- Known Use Problems List
- Formative Evaluation Protocol and Report Template
- Summative Usability Test Protocol
- Summative Usability Test Report
Is this right for you?
We believe in being upfront. Here's who this pack works best for.
- Medical device teams building a usability engineering file under EU MDR or FDA human factors guidance
- UX researchers and product designers working on medical devices
- QA and regulatory affairs professionals responsible for IEC 62366-1 compliance records
- Startups developing medical devices needing a structured human factors process
- Organizations already certified with complete usability documentation
- Teams only needing specific usability engineering documents
- Those unfamiliar with IEC 62366-1 requirements
Why teams choose this pack
Practical benefits without the hype. Here is what you actually get.
Clarity from the start
No more staring at blank documents. Each template shows you what belongs where and why it matters.
Hours saved on structure
Skip the research phase. Start with proven layouts that align with regulatory expectations.
A path to follow
The included guides give you a practical sequence so you know what to tackle first.
Foundation to build on
These templates grow with you. Adapt them as your compliance program matures.
Questions about this product
Common questions specific to this template kit.
Ready to get started?
Skip the blank-page anxiety. Start with structure that aligns with IEC 62366-1 and adapt it to your context.
Instant download. Free updates. Single organization license.