Q
Does anyone have any experience with using the Rational Unified Process (RUP) for the development of medical device software and are there any quality system regulations (US or EU) that present barriers to its use? I'm assuming there aren't and the regulatory requirements would just be considered as design inputs and RUP provides adequate design control, traceability, records etc....., but I just wanted to see if I was missing something.
Any thoughts would be greatly appreciated!
Any thoughts would be greatly appreciated!