chapter  5
10 Pages

The Special Case for Software

Since the time software was first used in a medical device, it has always been treated as a special entity by standards and regulatory agencies. Because it was something that could not be touched, it has been treated as if it were some alien life form come to test the resolve of any standards or regulatory professional. In part, this has come from an apparent lack of understanding of what software really is and how it performs, thus leading to over regulation.