FDA officially recognizes HE75 Human Factors Standard

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S

sl344

#3
What is the relationship between HE75 and 62366? How to know when to use one or the other or both?
 
Q

Quality Julie

#9
Can someone please help me with applying EN 62366:2008 to a simple in vitro diagnostic medical device, i.e. home pregnancy test and ELISA reagents for professional clinical labs. I find this FDA document much easier to get through, but I'm trying to update our Risk Analysis SOP to include EN 62366:2008 and for a simple IVD, we already do user studies in their home environment for self-testing products as well as flex studies, where we simulate potential mistakes by the user by longer incubation times, etc. Our ELISA kits are reagents used by professional labs where the assumption is they can operate a pipette and use a timer. We do extensive inter and intra assay validation for our ELISA's. We've been manufacturing these reagents for many, many years and use the same basic set of instructions. I'm responding to an ISO 13485 audit and other than updating our risk analysis SOP to include a specific section on useability and updating our List of Essential Requirements to include this standard just to please the auditor, I can't imagine doing much more. Any practical advise would be appreciated. Please don't respond with a reiteration of the standard or philosophical opinion, I'm searching for practical advise from an IVD manufacturer who has to comply with a standard that was originally designed for the electric/ mechanical field. Thank you!!!:bonk:
 
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