B
Refer to IEC/TR 62366-2:2016: Guidance on the application of usability engineering to medical devices - Section 18 Document the USABILITY ENGINEERING project.
It provides for a structure of a Usability Engineering Report.
Also refer to Annex D (informative) USABILITY ENGINEERING project end products - that provides for with information required by -1 and -2. Note that -2 is more comprehensive compare to -1.
We structured our Usability Engineering Report based on the guidance.
Expect the Test Report Form to be based on clauses requirements from -1, that will be evidenced in reference to the Usability Engineering Report / File, along with a test verdict.
It provides for a structure of a Usability Engineering Report.
Also refer to Annex D (informative) USABILITY ENGINEERING project end products - that provides for with information required by -1 and -2. Note that -2 is more comprehensive compare to -1.
We structured our Usability Engineering Report based on the guidance.
Expect the Test Report Form to be based on clauses requirements from -1, that will be evidenced in reference to the Usability Engineering Report / File, along with a test verdict.