Demonstrating your device can be used safely and effectively by real users — to IEC 62366-1 and FDA human factors guidance.
A multidisciplinary team — engineering, design, and behavioral science — running formative and summative studies in controlled, simulated-use environments.
Design out use error before it reaches validation.
We start from a use specification and a use-related risk analysis (URRA), identify the critical tasks where use error could cause harm, and run iterative formative studies throughout development. Each round feeds directly back into the user interface, instructions for use, labeling, and training — reducing risk while changes are still inexpensive. Our approach follows IEC 62366-1 and the FDA's human factors guidance.
The human factors evidence your submission depends on.
We design and execute summative human factors validation studies with representative users in realistic use environments, covering every critical task. We manage participant recruitment and screening, moderate and record the sessions, analyze use errors and their root causes, and author the HFE/UE report that supports your FDA or EU submission.
Define intended users, use environments, and the tasks where use error could cause harm.
Iterative studies through design that surface and eliminate use errors early.
Validation studies and analyses with representative users in a realistic environment, covering all critical tasks.
The engineering report and residual-risk conclusions that support your submission.
A full toolkit spanning analytical, formative, and validation work, aligned to IEC 62366-1:2015 and FDA human factors guidance.
Contact us to plan formative and summative studies that de-risk your submission.
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