• Direct your organization to achieve IEC/ISO 62366 compliance.
  • Satisfy human factors requirements for initial FDA pre-market and 510K submission.
  • Exploratory and Validation (Formative and Summative) Usability Testing.
  • Usability Testing Facility to meet testing needs; from home use devices to surgical instruments and imaging.
  • Interpret and satisfy FDA submission discrepancies related to human factors.
  • Lead or consult your organization in the design and execution of a predictive use error analysis (generally in the form of a uFMEA).
  • Provide input for CAPA activity and resolution for items related to use error.
  • Generate user needs to define general design direction and user requirements to input the design process.
  • Embed within your development organization to provide user centered input to the design decision process. This is done through use environment evaluation, usability testing, and analytical assessment of current concepts.
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