Dear All,
Merry Christmas and Happy New Year,
Just want to check whether anyone has a summary or a list of requirements for usability/human factors engineering, including standards (e.g. CLSI or others) specifically for IVD medical devices. I know that there was "GP14-A Labeling of Home-Use In Vitro Testing Products; Approved Guideline, which described a lot about "pre-testing" like readability testing, focus interviews, ....etc, which are essentially usability testing alike, but the standard seems to be withdrawn.
Any idea or help?
Best regards!!
Merry Christmas and Happy New Year,
Just want to check whether anyone has a summary or a list of requirements for usability/human factors engineering, including standards (e.g. CLSI or others) specifically for IVD medical devices. I know that there was "GP14-A Labeling of Home-Use In Vitro Testing Products; Approved Guideline, which described a lot about "pre-testing" like readability testing, focus interviews, ....etc, which are essentially usability testing alike, but the standard seems to be withdrawn.
Any idea or help?
Best regards!!