Firstly, how would the pack apply to Software as a Medical Device (SaMD)? Looking at the preview there is a lot that seems unnecessary as it is focused on the development of a physical product?
Secondly, on the software front where would Software Requirements be specified (e.g SRS Doc) is this kept as an external doc and referenced? On a similar line, what about Software Testing (e.g. unit testing, user testing)? Would you again keep an external record and link to it in the “Record of Software Validation”?