I
In IEC62304, it is left to the manufacturer to provide the definition and granularity of Software Items and Software Units.
Can anyone offer guidance or share industry experience in the practical definition of a software unit? I am guessing there are at least three important factors, maybe more. I am working with various engineering groups in our organization and we are attempting to define what a software unit is to us.
I imagine that one might be whether the software is releasable as one of many software components in a system - as a configuration entity that is independently releasable.
A second might be based on architecture; a truly logical separation of functions.
A third might be based on effort or management of the program; how the work is subdivided between resource pools (e.g. outside resources contracted to perform portions of the development). This could also be be based on internal effort - project management concerns may choose to further decompose "large" efforts into smaller manageable pieces.
Are there others? Is there any industry guidance for this activity?
Can anyone offer guidance or share industry experience in the practical definition of a software unit? I am guessing there are at least three important factors, maybe more. I am working with various engineering groups in our organization and we are attempting to define what a software unit is to us.
I imagine that one might be whether the software is releasable as one of many software components in a system - as a configuration entity that is independently releasable.
A second might be based on architecture; a truly logical separation of functions.
A third might be based on effort or management of the program; how the work is subdivided between resource pools (e.g. outside resources contracted to perform portions of the development). This could also be be based on internal effort - project management concerns may choose to further decompose "large" efforts into smaller manageable pieces.
Are there others? Is there any industry guidance for this activity?
Im trying to read IEC62304 definitions very, very carefully! I read under the definition of a software item that "it is left to the manufacturer to provide the definition and granularity of Software Items and Software Units" and under software Unit that it is an "item that is not subdivided into other items".
?

