Summative evaluation

The summative evaluation is the validation of safe use. It is usually a usability test with representative users, and FDA expects it to cover the critical tasks.

USER INTERFACE EVALUATION conducted at the end of the USER INTERFACE development with the intent to obtain OBJECTIVE EVIDENCE that the USER INTERFACE can be used safely Note 1 to entry: SUMMATIVE EVALUATION relates to validating the safe use of the USER INTERFACE.

IEC 62366-1:2015+AMD1:2020, clause 3.13