Loring Human Factors
We help our clients design seamless, safe, and successful user experiences through Design Research & Human Factors Engineering. Our offerings include:
User Research
User Interface Design
Usability Testing
Early prototype tests
Cognitive walkthroughs
Directional and preference tests
Formative usability tests
Baseline and benchmark tests
Remote usability tests
HF/UE summative/validation tests for FDA
Expert Reviews
Sometimes it makes sense to have one or more human factors experts review your product design before conducting a test with users, to catch any obvious usability issues. We conduct expert reviews based on HF principles, decades of experience, industry standards, and design heuristics to deliver specific recommendations for improvement.
Medical Device Regulatory Advice
Medical device manufacturers often need expert guidance on designing and scoping a human factors/usability engineering (HF/UE) program for a device or system. We have extensive experience helping clients implement usability engineering programs that meet the requirements of IEC 62366-1 and the U.S. FDA. Considerations include whether it is a new or legacy device, the device class (I, II, or II), known use errors, and level of risk.
IEC 62366-1 and FDA Guidance audits
HF/UE plan development
Documentation gap analysis
Review of FDA responses
HF/UE process development
Use-related hazards and risks analysis
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