I made medical imaging software for diagnosis and analysis. We would get a regulatory proctology exam every release. These guys would find arithmetic errors in papers referenced to support algorithms used in the software, and ask us about them. (Incidentally, that's where I learned never to trust "peer reviewed" papers or dissertations in computer science. Always check it, in detail, yourself. CS guys have to be some of the worst mathematicians I've seen during my time in scientific research.)
But yeah, the FDA were that anal in our case. If they were not that anal for you, I'm not sure why that is? Maybe the radiation? We were putting out software that potentially dealt with, essentially, irradiating humans. Software that controlled radioactive devices. Etc. No one wants the equivalent of a dirty bomb going off in some small town somewhere. So I don't blame the FDA for the whole "every i dotted, every t crossed" treatment. It was actually reassuring. At least in our case.
But even in the US, medical equipment breaks down. Just not at near as high a rate.