What are the specific requirements for this, for an MDR, or IVDR MDSW
I heard some comments about requiring a "build SOP" to allow someone to recreate the software in its entirety but I don't think I have ever seen a dedicated SOP for building
I've written DMRs for physical products including the process descriptions, intermediates, specs and plans, but for MDSW what (and where) and the specific regs/reqs and how is it usually managed in practice, isn't a zip file of all source code and a good definition of your configuration items enough "to be able to recreate" the software.
I heard some comments about requiring a "build SOP" to allow someone to recreate the software in its entirety but I don't think I have ever seen a dedicated SOP for building
I've written DMRs for physical products including the process descriptions, intermediates, specs and plans, but for MDSW what (and where) and the specific regs/reqs and how is it usually managed in practice, isn't a zip file of all source code and a good definition of your configuration items enough "to be able to recreate" the software.