Yep, part of the quality standard for medical devices is to have processes, and also processes to improve and change the processes. So theoretically there shouldn't be any doubt as what to do in a given circumstance when something fails, and that standards would rise as development matures. But in reality it's just a bunch of paperwork, and as far as the software is concerned, standard practices of unit and integration testing, code reviews, and strict compiler settings are more than adequate already.

Edit: It's all about documenting that those things have been done and signed off on, so keeping track of paperwork.