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Not too much actually. You need to have a design history file (DHF) and a Failure-Mode Engineering Assesment (FMEA) document as part of your "Quality" system fo
by officialchicken 10y ago
Not too much actually. You need to have a design history file (DHF) and a Failure-Mode Engineering Assesment (FMEA) document as part of your "Quality" system for FDA submission, usually at the time the project starts. Defining and using agile methodologies forces those documents/proceedures to be more in-sync with the software system and any unit/system/e2e testing and CI. It also formalizes the testing process - bringing some structure to the agility of your chosen methodology.