Usability engineering

The process usually follows IEC 62366-1 and, in the US, FDA's human factors guidance. It ends with validation testing that shows intended users can perform critical tasks safely.

application of knowledge about human behaviour, abilities, limitations, and other characteristics to the design of MEDICAL DEVICES (including software), systems and TASKS to achieve adequate USABILITY Note 1 to entry: Achieving adequate USABILITY can result in acceptable RISK related to use.

IEC 62366-1:2015+AMD1:2020, clause 3.17

Application of knowledge about human behaviour, abilities, limitations, and other characteristics to the design of and interactions with an IVD medical devices (including software) to achieve adequate usability.

MDCG 2022-2, Section 4, Definitions (modified from IEC 62366)