1. Regulatory References
Regulatory references:
IEC 62304, para. 5.3.1 and 5.3.2 [class B, C]
Relevant other documentation:
- SOP Software Development
- User needs / stakeholder requirements
- Design input / software requirements
- (…)
2. Software Systems
In compliance with DIN EN 62304, we subdivide our software on three levels: software systems, software components and software units.
Here, describe your internal software systems. The IEC 62304 defines those as an “integrated collection of software items organized to accomplish a specific function or set of functions.”
NOTE: Ideally, you would add an illustrating diagram to the Annex and reference it here.
4.1. Frontend
Enter description, for example:
- Function: user interface display
- Software safety classification and rationale
- Runtime
- Deployment
- User groups
4.2. Backend
Enter description, for example:
- Function: managing patient data and medical images.
- Software safety classification and rationale
- Runtime (e.g. JVM)
- Deployment (e.g. Docker container)
- User group
4.3. Algorithm
Enter description, for example:
- Function: taking medical images as input and output a prediction.
- Software safety classification and rationale
- Runtime (e.g. JVM)
- Deployment (e.g. Docker container)
- User group
6. Software Units
Describe your internal software units. The IEC 62304 defines those as a “software item [any identifiable part of a program, i.e. source code, object code, control code, control data, etc.] that cannot be subdivided into other items”. For example:
- Wearable device poller (regularly checks whether wearable device has new data and downloads it)
- Notification service (sends messages to Apple / Google for push notifications of mobile apps)
- (…)
7. Database
Describe your databases. For example:
- Relational database: Postgres v14
8. IT Security
8.1. Encryption of data
<enter content>
8.1.1. Data at rest
<enter content>
8.1.2. Data in transit
Example content:
- Data in transit is encrypted with state-of-the-art encryption, e.g. SSL, TLS.
- Additionally, we create a Virtual Private Network (VPC) which prevents the Compute Instances from being exposed to the public internet. The algorithm and the database are therefore not publicly reachable; they are only reachable by the backend.
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