Usability

Human Factors & Usability Engineering is critical in designing safe, effective, medical devies. Human Factors Engineering addresses key considerations of how device design impacts use of the device. Assessing ergonomic usability of your device is critical in overall operational profile. Human Factors Engineering testing, formative and summative, is executed in compliance with IEC 62366.

Eurofins Medical Device Consulting provides industry-leading expertise in developing and executing those studies.

Our services include creating a test protocol specific to the design and intended use of your device. Upon executing formative and summative studies in our industry-leading labs, we provide an extensive usability evaluation report for further analysis, and inclusion in your premarket submission.

Human Factors & Usability is integral to overall risk analysis, enabling a wholistic assessment addressing potential risks associated with user errors, ergonomics, and other factors with implications in overall device safety and efficacy.

We offer evaluation in both the early stages of device design and during the advanced development phases, facilitating improvement across the medical device lifecycle. In addressing early-stage usability concerns, we provide extended pathways for addressing related issues.