1
关注
1064
浏览

How to determine the naming rules for softwareversion?

您还未登录!暂时最多只可查看 1 条回答

登录! 还没有账号?去注册

ku1314520 一阶会员 用户来自于: 广东省深圳市
2023-09-17 22:11

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.


关于作者

问题动态

发布时间
2023-09-17 22:10
更新时间
2023-09-17 22:11
关注人数
1 人关注

推荐内容

神经和心血管介入导管类产品导管座如何进行生物学评价?
How to select EMC test samples?
体外诊断试剂产品技术要求附录中主原材料的供应商该如何填写?
提交体外诊断试剂第二类产品拟上市注册时,对于已获得批准的检测系统的其他组成部分应提交什么资料?
以免疫层析法为检验原理的定性体外诊断试剂进行精密度研究时有哪些考量因素?
定量检测体外诊断试剂的精密度试验设计,是否要对各影响因素进行单独评估?
申报产品中既包含颈椎椎间融合器和腰椎椎间融合器,若开展临床试验,是否可以只选其中一种融合器做临床试验?
2014年10月1日前获批医疗器械产品,如注册产品标准发生变化,如何提出申请,能否通过注册变更申请直接将标准转换为产品技术要求?
医学影像相关产品使用人工智能算法进行图像识别以实现测量功能,此类产品是否属于第二类医疗器械?
口腔车针、牙钻产品如何设定货架有效期?