How can we write software requirements? Should we use user stories? Or rather draw old-school UML and context diagrams? Just screw everything and describe the features in whatever way we want?
We'll start writing software requirements by starting out with the OpenRegulatory template, copying it to Google Sheets and typing on our keyboard.
Along the way, we'll solve a few more problems:
Traceability: How can we make software requirements uniquely identifiable for traceability, which is an important 62304 requirement?
Database: Specify the database as requirement?
Software systems: How can we specify software requirements if they relate to different software systems (in the 62304 sense)?
Related risks: How can we document related risks and link those to the risk analysis? We won't go into much detail here as the ISO 14971 - compliant risk analysis is another topic which you as a software developer hopefully don't have to deal with full-time.
Risk control measures: How to define a software requirement as risk control measure.
Security requirements: How to define IT security requirements.
- Deployment / installation requirements
We'll also think about what could go wrong in our software: What happens if it predicts that a patient has covid while the patient is actually healthy? What about the opposite?
Also, remember the geographical user location being saved? We definitely need to document our risk control measure that locations are being anonymized.