Version

Any change to a version of medical device software creates a new version and needs configuration management. Version identification is what lets a manufacturer know which software is in which device.

identified instance of a CONFIGURATION ITEM NOTE 1 Modification to a VERSION of MEDICAL DEVICE SOFTWARE, resulting in a new VERSION, requires software configuration management action. NOTE 2 Based on ISO/IEC 12207:2008, 4.56.

IEC 62304:2006+AMD1:2015, clause 3.34