Re:Ask HN: I’m an FCC Commissioner proposing regulation of I...
by robertlagrant on Wednesday September 06, 2023 @12:05PM
(#37407099)
Agree; I make software as a medical device. My point is you often don't have to do that. You just have to fling a lot of paper at an auditor, which can be generated well (as you describe, and as I would do, and the good companies in my example would already do) or badly (which the bad companies in my example would do) where it's basically generated post hoc in a hurry.
You might think these kinds of things are table stakes, and I would agree.