Description
Usability Study Report (Human Factors)
Comprehensive human factors/usability engineering documentation meeting FDA and IEC 62366-1 requirements — essential documentation demonstrating safe and effective user interaction. We prepare the use specification, use-related risk analysis, formative and summative (validation) study reports, and the complete human factors engineering file.
Service Details
| Turnaround | Report development: 4–6 weeks post-study; full study support: 12–16 weeks |
| Best for | Demonstrating safe and effective user interaction under FDA and IEC 62366-1 requirements |
| What you receive | Use specification, use-related risk analysis, formative evaluation reports, summative (validation) study report, and human factors engineering file |
| Device types | Combination products, home-use devices, SaMD, implantables, and in-vitro diagnostics |
Regulatory Framework
- FDA Human Factors Guidance – Applying Human Factors to Medical Devices
- IEC 62366-1:2015 – Usability engineering
- IEC 62366-2:2016 – Guidance on application
- ANSI/AAMI HE75 – Human factors engineering
- EU MDR – Annex I usability requirements
Documentation Package
- Use Specification – Intended users, use environments, user interface
- Use-Related Risk Analysis – Critical tasks, use errors, hazardous situations
- Formative Evaluation Reports – Iterative testing results
- Summative (Validation) Study Report – Final usability validation
- Human Factors Engineering File – Complete documentation
Study Components
- Study protocol
- Participant demographics
- Task scenarios and success criteria
- Use error analysis
- Knowledge task results
- Root cause analysis
- Risk-benefit conclusions
Device Types
- Combination products (drug delivery)
- Home-use medical devices
- Software as Medical Device (SaMD)
- Implantable devices
- In-vitro diagnostics
How It Works
- Send us your device information, intended users and use environments, and any existing study data or reports
- We prepare the usability documentation and study reports
- You review the drafts and we revise based on your feedback
- You receive the final study reports and human factors engineering file
Which Service Do You Need?
This service covers usability and human factors documentation. For the instructions for use themselves, see Instructions for Use (IFU) Development. For device risk management documentation (plan, analysis, evaluation, control, and report), see Risk Analysis Documentation.
Frequently Asked Questions
What documentation do you prepare?
The use specification (intended users, use environments, user interface), use-related risk analysis (critical tasks, use errors, hazardous situations), formative evaluation reports, the summative (validation) study report, and the complete human factors engineering file.
Which standards and guidance does it follow?
FDA Human Factors Guidance (Applying Human Factors to Medical Devices), IEC 62366-1:2015 usability engineering, IEC 62366-2:2016 guidance on application, ANSI/AAMI HE75 human factors engineering, and EU MDR Annex I usability requirements.
Which device types do you support?
Combination products (drug delivery), home-use medical devices, Software as Medical Device (SaMD), implantable devices, and in-vitro diagnostics.
How long does it take?
Report development takes 4–6 weeks after your study is complete. Full study support takes 12–16 weeks.
Get started: add this service to your cart, or email co*****@*******se.com with your device type and whether you need report development or full study support to discuss scope.
