I need to produce some documentation to be compliant with IEC 62304 and, while reading all of the processes needed to be documented, I'm having a couple doubts about how to structure the whole lot of documentation.
My concern is about how to divide all of the documentation in separate documents and what should be included.
The whole software system can be considered composed of 3 main subsystems:
- Firmware on embedded device (#1)
- A companion Android Application (#2)
- An application backend used to ingest, process and save data from the devices (#3)
I'm especially in charge of the latest, which is a fairly streamlined streaming-oriented application which processes and saves data on a DB (a SOUP, in the case of IEC 62304 compliance).
Now, the data saved in the DB is visualized in a Grafana dashboard: in which document should this component be considered? What should be the limit of the scope regarding the #3 application and its interaction with the other components? Since Grafana would be a SOUP, I was thinking about writing about it in the appropriate document where all configurations and SOUP management is. Should I mention/reference inside the SRS of #3 application the requirements for the needed visualizations? Which is the appropriate document where I should put this information?
I'm using as a template reference for all of the documentation needed this blog, since I'm new to software development with ISO/Standard Regulations, but any additional resources as to how structure the whole docs in this context is highly appreciated.