Human Factors and Usability Testing for Medical Devices
Our team is equipped to lead formative, ergonomic, and feasibility studies, ensuring comprehensive insights prioritize product usability and safety.
Expertise areas
Formative Studies
Early use testing to discover what users want and rapidly improve the product’s usability, safety and performance. Qualitative and quantitative analysis help us turn data into actionable insights for iterative design improvements.
Usability Validation / Summative Studies
A critical component of FDA medical device applications, we run Usability Validation studies to verify that a device will be safe and effective for the intended users, uses and use environments.
Human Factors Risk Management
Use Failure Modes and Effects Analysis (UFMEA) and gap analysis to reduce risk and inform design input requirements.
IRB Management and HFE Reporting
Identifying an appropriate supplier to manufacture a product is crucial to a company's success. We have a vast network of recommended manufacturers and will be there to support you along the way.
Ergonomic Studies
Using anthropometric data, task analysis, and observational studies with real users to improve physical and cognitive ergonomics for better usability.
Our services
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