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.
Result: A properly scoped HF/UE effort for a given program; avoiding costly delays due to inadequate HF/UE submissions.
Services:
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IEC 62366-1 and FDA Guidance audits
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HF/UE plan development
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Documentation gap analysis
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Review of FDA responses
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HF/UE process development
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Use-related hazards and risks analysis
Deliverables:
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IEC 62366-1 gap analysis
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FDA Guidance gap analysis
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Usability engineering plan
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FDA meeting support
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HF/UE procedure and templates
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Use-related hazards and risks analysis (URRA)