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