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:

  • 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

Deliverables:

  • IEC 62366-1 gap analysis

  • FDA Guidance gap analysis

  • Usability engineering plan

  • FDA meeting support

  • HF/UE procedure and templates

  • Use-related hazards and risks analysis (URRA)