# Software Architecture Description

Author: Sven Piechottka
Published: 2022-08-31
Updated: 2024-04-26
Source: https://openregulatory.com/document_templates/software-architecture-description

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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.
2.1. Frontend
Enter description, for example:
Function: user interface display
Software safety classification and rationale
Runtime
Deployment
User groups
2.2. 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
2.3. 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
3. 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)
(...)
4. Database
Describe your databases. For example:
Relational database: Postgres v14
5. IT Security
5.1. Encryption of data
<enter content>
5.1.1. Data at rest
<enter content>
5.1.2. 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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