Developing Software for Medical Devices – Interview with SterlingTech gives a good overview of the challenges that especially face young medical device companies. In particular (my emphasis):
Make sure that your company has a good solid Quality System as it applies to software development. Do not put a Quality System into place that you can not follow. This is the cause of most audit problems.
I couldn't have said it better myself, though I think that focusing on the FDA may distract you from why you're creating software quality processes in the first place. The real purpose of having software design controls is to produce a high quality, user friendly, robust, and reliable system that meets the intended use of the device. If your quality system does that, you won't have to worry about FDA audits.
Since Klocwork is a static analysis tool company I also want to point out a recent related article that's worth reading -- and trying to fully understand:
A Few Billion Lines of Code Later: Using Static Analysis to Find Bugs in the Real World
Note the user comment by Bjarne Stroustrup.
UPDATE (2/9/10): Here's another good code analysis article:
A Formal Methods-based verification approach to medical device software analysis
