Even though we are probably going to classify the software as Class A based on IEC62304. However, I do not feel comfortable to develop the software without software architecture,detailed design,verification, integration testing, system testing...
I feel so akward to skip those activities. why would any medical device manufactuer ever develop and release any software without testing??? don't you think we have to follow basic software engineering techniques even if it is not an medical device software?
I came from a consumer software industry, I really don't see the meaning of having a class A in medical device software safety classification. To me, Class A allows people develop the software and release it without making sure it satisfies the requirements. what is the point even to have an SRS at all?
maybe I missed something. If that's true, sorry about that.