The software version is used to identify the software status and to control the software update. The naming rule of software version is decided during the software development process according to its own features, and used to identify the features of software development and update.
For medical device software, in addition to its own features and quality management system, regulatory requirements should also be considered, so as to reflect and identify different types of update and to determine the complete version and release version of the software.
The software version can be named in different ways according to the situation, and does not have to be named in the way of X.Y.Z.B. Manufacturers shall make clear all the segments of the software version and the meaning of each segment, and determine the complete version and the release version of the software.
If one segment of the software version could reflect either major or minor update, then according to the risk principle this segment should be considered as major update and be included in the release version.
Sources: NMPA
