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Design Assurance

Our product development process fully complies with the design assurance guidelines outlined in FDA 21 CFR 820, ISO 13485, and adheres to the FDA and European human factors guidelines including HE 75 and ISO 62366 and incorporates risk management per ISO 14971.

Services include but are not limited to:

  • Risk Management
  • Use Related Risk Analysis (URRA)
  • Human Factors / Usability
  • Failure Mode Analysis (dFMEA, pFMEA)
  • Design Input
  • Verification and Validation
  • Design Outputs
  • Trace Matrix Requirements Mapping
  • Design History File
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Human Factors Engineering
Eclipse-Developed Medical Cart Wins MDEA Bronze Award

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