@Andrew, @schuemie, friends:
Before we stray too far from the path: Apart from this not being a regulation but just a guideline, and it not even being issued by the FDA but IMDRF, it pertains to Software as a Medical Device. And that is defined as software that does one of the following:
- diagnosis, prevention, monitoring, treatment or alleviation of disease,
- diagnosis, monitoring, treatment, alleviation of or compensation for an injury,
- investigation, replacement, modification, or support of the anatomy or of a physiological process,
- supporting or sustaining life,
- control of conception.
So, patient care. We do none of that. At least not now. When we start pushing our stuff out to individual patients or providers handling individual patients, we may be getting closer to what the intention of these guidelines is. Of course, it's always good to get good ideas and hints about how to do software validation right, if that's what you had in mind.