Hello,
I have a question concerning the formative evaluation of a stand-alone medical software, do you have an example of formative evaluation report according to IEC 62366?
Thank you for your feedback,
Summaries of formative testing only need to be as precise as necessary to drive design input requirements, clarify user specifications, inform use cases (for risk analysis). Summative testing is a different story!
Suggested Resources:
62366-2 (simply report on activities performed in section 16, anyone who has written a report for something like 60601-1 can follow this)
HE75:2009 (chapter 21 is quite informative w.r.t. Software Interfaces)
The DOE Handbook won't specifically satisfy your request, but I include it because chapter 2 is the most straightforward explanation of where use failure modes "come from", and it is 100% applicable to usability analysis in all fields (including medical devices and non-medical software systems). If nothing else, the glossary in the back ought to clarify terms that folks may not have encountered before.
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