Please link me to the regulations that require you to wait weeks for approval to change a line of code during device development (BEFORE deployment). After deployment, you need to do a lot of paperwork and testing to change anything, whether it is a drug, medical device, or clinical test and for good reason. You can't just do a git push when you're building a complex system where a misplaced bit can easily kill someone.

As for my anecdotes, I worked on bringing online robotics and brand new diagnostic tests (with and without golden standards) which are under entirely different regulations than record keeping or the day to day operations of a lab.