Product Overview
Medical Device Human Factors Engineering
Confirms user-friendly device design to comply with FDA usability standards.
Human factors engineering is an integral part of both medical device usability and safety (HE75 and IEC 62366-1). The process that we use helps us to clearly understand how users interact with your medical device product in a real-life and clinical environment. This, in turn, helps us to both reduce risk and improve performance, while meeting and maintaining FDA requirements for usability validation.
Our human factors practice is completely integrated with your development timeline. We start with formative testing that can be used to understand and influence design decisions, through to summative testing to validate the safety and performance of your device.
We conduct thorough use-related risk analyses to spot any possible hazards, and we create design controls that minimize user error throughout the product development cycle.
Our systematic observation and experimentation let us quantify cognitive workload, physical ergonomics, and environmental factors that affect device operation. Our specialists check user workflows, task sequences, and decision-making patterns to optimize usability. This step reduces the likelihood of failure modes.
Our testing looks at both documented use scenarios and plausible misuse conditions. We stress-test the products with diverse user groups and various levels of experience, physical capabilities, and stress conditions likely to be encountered in a clinical environment. Our thorough coverage makes your device work reliably for experienced professionals as well as for occasional users.
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