Do you follow your QMS for non-device software features?

SSchoepel

Involved In Discussions
#1
Previous places I have worked keep track of all features, regardless of whether they are considered a medical device (by the FDA).

Currently I am getting pushback on whether to write user needs and requirements, risks, etc. for something that is clearly not a medical device per the guidance. I say it's worth keeping track so we know whether we are making changes to or finding issues with the medical device or the non-medical device. (They also want to count adding the features as a patch and not a full release.)

I don't need much information, just whether or not your present company or previous companies tracked non-medical device software features through the QMS.
 
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yodon

Staff member
Super Moderator
#2
Is the software part of the device, just not performing a medical function? Who is the intended user of the software and what's its intended purpose?
 

SSchoepel

Involved In Discussions
#3
Is the software part of the device, just not performing a medical function? Who is the intended user of the software and what's its intended purpose?
Yes. It's a SaMD and there are features that clearly are clinic management (assignment of tasks to clinicians, no assessment/diagnosis/treatment). And the users would be the clinicians themselves and maybe someone like a nurse navigator. They'd assign each other things to do in the medical device but it doesn't control anything in the device.
 

yodon

Staff member
Super Moderator
#5
Unless the "non-medical" part is a completely separate software application, it will be a challenge (if not impossible) to manage one part as 'not a device.' Under 62034, if you architect thing properly, it would be permissible to have different software classes (although reviewers have a very hard time with this). The non-medical device part could be Class A, a lower burden; however, even Class A requires, well, requirements (and testing).

If the non-device part had anything to do with protected health info / private information then that may elevate it even further. If you incorporate software you didn't write (aka SOUP or Software of Unknown Provenance), you'll need to jump through some hoops (both on the device part and the not device part). If your device / software hooks into a network then you probably have substantial cybersecurity concerns. Lots to consider beyond whether it's performing a medical function or not!
 
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