Medical Device Software Version Naming Rules

Nowadays, the updating of the software version is rapid. It followed with the updating of software version that is really important for the medical device manufacturer and medical device supervision institutions. Software version is not only the approach to ensure the medical device software quality control and the component of the quality management, but also the identification of the software.

It is therefore that medical device companies should be aware of the medical device software version naming rules. For medical device area, the updating of software will be different from different point of view.

Point of View	Updating Type
Regulation	Major updating, slight updating
Technique	Upgrade updating	Adaptive(adapt to new operating environment)
		Perfection (change the software properties like function, performance and etc.)
	Correcting Updating	Correction( correct the known defects of the software)
		Prevention( correct the unknown defects of the sofware)
Special Case	Construction: regard as correcting updating
	recall：regard as major updating

The upgrade and perfect updating both belongs to major updating except slightly upgrade updating, such as the operation platform of software change to a incompatible computer platform. The updating of the software will influence the clinical decision of user, personal safety. Also, the updating of the safety level, system construction, user interface relationship and the physical topologyall belongs to major updating.

Medical Device Software Version Naming Rules

X：Major upgrade updating
Y：Slightly upgrade updating
Z：Correcting updating
B：Construction

Ex: A software version V1.0.0.0
The complete version should be X.Y.Z.B, and the released version is X. If the version X changes, companies should be care about the permitted item modification of the registration. But when Y, Z, B change, there is no need to change the registration.

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