Human factors engineering

Human factors engineering looks at how real users, in real environments, interact with the device and where use errors could cause harm. It runs through the whole design process, not just a test at the end.

Human factors engineering refers to the application of knowledge about human behaviour, abilities, limitations, and other characteristics to the design of and interactions with a MDSW to achieve adequate USABILITY.

MDCG 2020-1, Section 3.3, Definitions

Application of knowledge about human behavior, abilities, limitations, and other characteristics to the design of medical devices (including software), systems and tasks to achieve adequate usability.

FDA guidance: Applying Human Factors and Usability Engineering to Medical Devices (August 2026), Section 3, Definitions