Andrew Dallas’s article Caution: V&V May Be Hazardous to Software Quality touches on a number of good points regarding software quality best practices.
Medical device software development V&V (also see here) and the documentation that goes with it have substantial costs. Any strategy that can reduce this overhead and still meet the necessary quality standards should be seriously considered.
The use of “incremental” software development approaches really refers to Agile methodologies. I’ve talked about the use of Agile for medical device software development several times:
Most of the discussion revolves around the risks associated with this approach. The benefits of any process change have to be weighed against the possible risks that might be introduced.
Besides the importance of understanding what V&V documentation the FDA actually wants to see, Andrew makes a great point about producing quality software versus the V&V process (my highlight):
V&V is not software testing. Verification testing ensures specified requirements have been fulfilled. Validation testing ensures that particular requirements for a specific intended use can be consistently fulfilled.
Following the required FDA V&V processes alone is not sufficient to ensure software quality. You also have to adhere to software development best practices at all levels. For example, in addition to non-functional requirements there are many software quality factors that require careful design considerations and testing that you may decide are outside the scope of FDA reporting. Deciding what to report and what to leave out is the balancing act.