For more information about the role of software in medical devices in the context of the 510(k) process, see my IOM webcast, the IOM report on Trustworthy Medical Device Software, and publications on the SPQR Lab website. The PDFs are free at the IOM, but there's a clumsy registration process through which one must first wade.
I decided to run the IOM report through Wordle to visualize topics of emphasis. I removed most of the header information before processing. Look below if you want a PDF of higher quality.