I have to create documentation that complies with IEC 62304. When reading all the processes that need to be documented, I have some doubts about how to structure the entire documentation.
My concern is how the entire documentation is divided into separate documents and what should be included.
The entire software system can consist of 3 main subsystems:
- Firmware on the embedded device (# 1)
- An accompanying Android application (# 2)
- An application backend used to collect, process, and store data from the devices (# 3)
In particular, I'm responsible for the latest application, a fairly flow-oriented, flow-oriented application that processes and stores data in a DB (a SOUP in the case of IEC 62304 compliance).
Now, the data stored in the database is visualized in a Grafana dashboard: In which document should this component be taken into account? What should be the limit of scope for the # 3 application and how it interacts with the other components?
Since Grafana would be a SOUP, I thought about writing it in the appropriate document that contains all the configurations and the SOUP management.
Should I specify the requirements for the required visualizations in the SRS of # 3 application?
What is the appropriate document to include this information in?
I use it as a template for all the documentation needed on this blog, as I'm new to software development with ISO / Standard regulations, but additional resources to help structure all documents in this regard are highly appreciated.