I have a solution that is representing my Medical device which is constructed of several components. Each component represent different part of the device and development on different time line and versions.
The solution version represent the Go To market release of the device there for its version can not be the same version of other components that build it.
Now I have according to the ISO 13485 and IEC 62304 set of documents that I need manage prepare and submit to the notify bodies.
Where should I put each document on the product tree?
My Tree looks like
MY Device 1.0 (Solution)
|->
|->
Device Software 7.0 (Project)
|->
|->
|->
Device Hardware 2.1 (Project)
|->
|->
|->
Device Mechanical 3.0 (Project)
|->
|->
|->