If you have spent any time reading guidance information from the FDA, you may have come away with a feeling of uncertainty or frustration that the guidance does not tell you *exactly* what to do to produce software that will be accepted by the FDA. The FDA guidance is general, by design, to not mandate an approach that can become out of date with evolving best practices and to not stifle creativity in how the industry approaches developing software for medical devices.

However, if you are developing a medical device with a software component for the first time, how can you have confidence that your software component will meet FDA expectations? The most successful method of gaining confidence is to have a firm with FDA approval experience perform an assessment of your software.