The software version is used to identify the software statusand to control the software update. The naming rule of softwareversion is decided during the software development processaccording to its own features, and used to identify the features ofsoftware development and update.
For medical device software, in addition to its own features andquality management system, regulatory requirements should alsobe considered, so as to reflect and identify different types of updateand to determine the complete version and release version of thesoftware.

The software version can be named in different ways accordingto the situation, and does not have to be named in the way of X.Y.Z.BManufacturers shall make clear all the segments of the softwareversion and the meaning of each segment, and determine thecomplete version and the release version of the software.
If one segment of the software version could reflect either majoror minor update, then according to the risk principle this segmentshould be considered as major update and be included in the releaseversion.