You might want to look into how often recalls are issued for medical software. Or not, if you prefer pisces of mind.

I'm sure all the time; all people and processes are fallible.

But that's also why documentation is so important in this space.

I spent 15+ years building software for pharmas that was subject to GxP validation so I know the effort it takes to "do it right", but also that it's never infallible. The main point of validation is to capture the evidence that you followed the process and not that the process is infallible.

Fishy

Yeah. All the talk about thinking computers, but I agree that intelligent fishes are a much larger threat.

> Medical software has to go through a validation process.

Guess what will power the validation process?

Think about those efficiency gains.