tech-file/DIN EN 62304/software-architecture-checklist.md
2022-12-23 13:39:17 +01:00

42 lines
1.8 KiB
Markdown

# 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\>\
---
Template Copyright [openregulatory.com](https://openregulatory.com). See [template
license](https://openregulatory.com/template-license).
Please don't remove this notice even if you've modified contents of this template.