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# Software Architecture Checklist

**Regulatory references:**

IEC 62304, para. 5.3.6 [class B, C]

**Relevant other documentation:**

- SOP Software Development
- User needs / stakeholder requirements
- Design input / software requirements
- Software architecture description
- (...)

## 1. Checklist

| Criteria                                                                                                 | Pass / Fail             |
| -------------------------------------------------------------------------------------------------------- | ----------------------- |
| The software architecture is in agreement with the software requirements.                                | ( ) Yes<br>( ) Improve: |
| All software systems are listed and their respective safety class is stated.                             | ( ) Yes<br>( ) Improve: |
| All software components are listed and described, including interfaces.                                  | ( ) Yes<br>( ) Improve: |
| All software units are listed and described.                                                             | ( ) Yes<br>( ) Improve: |
| (Optional) Further architecture is described, e.g. databases, security and data protection requirements. | ( ) Yes<br>( ) Improve: |
| The software architecture can be implemented with our given resources.                                   | ( ) Yes<br>( ) Improve: |

## 2. Comments

\<Insert comments if applicable\>

## 3. Results

( ) Software Architecture passed\
( ) Software Architecture not passed\
( ) Software Architecture passed with the following obligations: \<Insert if applicable\>\
