slicer.org has their detailed story why "3D Slicer is NOT FDA approved", and its unfortunate given the transient nature of volumetric imaging data formats.
My point was this area is a mine-field of regulation. Generally, the above rules trip the instant a doctor uses something to diagnose or communicate patient data. Notably, the same software is deployed across provinces and states... but will obviously have different certification requirements in each locale.
Some people seem to get really rude over the most mundane details. =3
Indeed, in your area this may be true. However, the health authority can't legally purchase or use these projects without the ISO certs, and thus it is a moot point.
I think we will have to agree to disagree, as there are two truths here. And people seem to be getting emotional about their egos. =)
I will mention that the certification process is expensive. It ranges in the 100K-250K range each time we go through it in fundraising and to go through the certification process.