- 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.
Bringing Focus to the Human Element
