Usability Engineering Report

Hello All,

I am currently working on a project that involves usability engineering, and I was wondering if you could kindly share Usability Engineering Report Template or important content for Class 1 device?

Thank you in advance for your help.

The standard doesn't require an overall report (although I would say that it's a good idea ... and we do one). 62366-2 lays out an outline for a usability *test* report (but that's probably not what you're after).

For our reports, we generally follow the FDA Guidance on applying HF/UE (see Appendix A).

Make sure your HF Plan/Report is tied into your risk assessments.