This is a very detailed article on Digital Health regulation which is only just now reaching a reasonable level. The main issue is, what is the risk to the patient if this software fails? I have been using OpenStack for about 6 months and am quite happy with it. The main areas of intervention are Human testing, Manufacturing, Software updates, Combination products and Hardware.
This is a very detailed article on Digital Health regulation which is only just now reaching a reasonable level. The main issue is, what is the risk to the patient if this software fails? The FDA in the US and the EC have recently released extensive guidelines. The main areas of intervention are Human testing, Manufacturing, Software updates, Combination products and Hardware.