[icegreentea]

I don't know how it works out for stuff used during surgery, but for diagnostic devices (where if a device fails by becoming inoperable, the stakes are a lot lower), you can lump basically any software that you don't have total control and design history on (so this includes random proprietary software and most FOSS stuff) as "software of unknown providence" (SOUP).

Now based on the class of medical device you are developing, you can either get to use SOUP without justifying at all, or you have to explain/justify why you can use SOUP at all.

For example, even if your OS was Linux, because you don't have formal documentation on verifying that Linux infact does all the things its suppose to do (hell, does Linux even have a true spec?), you would then have to justify why you're using Linux. If a kernel update comes out, you then have to justify why you're using it.

What you WOULD have to do is verify/validate that your software that interacts with SOUP (so in this case running on an OS) still works correctly. You would not have to verify/validate the OS update per se.