Software Requirements

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?

Yes, you are right, there are some procedures that you do not need as a manufacturer of Software, like Procedure for sterilization, or work environment. However, all other procedures are applicable for you like for any other manufacturer. I understand that your dilemma is whether to buy the whole toolkit or just some of its parts. For advice on which option is best for you in this case, our sales team will let you know.

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”?

Software Requirements can be set as an external document because it is rather specific for each software.

For any software testing that is necessary to be performed due to IEC 62304:2006 Medical device software — Software life cycle processes, we do not have such a template. This Documentation toolkit is concentrated on the requirements from ISO 13485 and general aspects of MDR. Since there is such a variety of medical devices, it was not possible to prepare templates for all kinds of tests.