Human factors
usability engineering
The engineering discipline of designing devices for the user, environment and task — with the goal of minimising use-related risk.
Human factors engineering (HFE) and usability engineering (UE) are functionally synonymous in medical-device regulation. FDA's 2016 guidance and IEC 62366-1 require a documented usability engineering process: user profile and use-environment analysis, task analysis, identification of critical tasks (those whose failure could result in serious harm), formative studies during design, and a summative human-factors validation with ≥15 representative users per distinct user group.
Use-error root causes from summative studies feed back into ISO 14971 risk control.
- FDA Guidance: Applying Human Factors (2016)
- IEC 62366-1:2015/AMD 1:2020
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