Talk:Detailed Clinical Models for Medical Devices
Regarding "The DCM criteria and methodology is addressed by ISO NIWP 13972, approved July 2009":
That's a New Work Item Proposal: i.e., it might be at the "committee draft" stage but I'm not sure it's even that far yet. Can any ISO experts clarify the status of that document?
The upshot being, we can certainly use 13972 to inform our efforts, but it appears to be a moving target, not a specification.