Regulatory References:
IEC 62304, para. 5.3.6 [classes B, C]
Other Relevant Documentation:
- SOP Software Development
- User and stakeholder requirements
- Design input and software specifications
- Software architecture documentation
- (…)
1. Evaluation Criteria
| Criteria | Pass / Fail |
|---|---|
| The software architecture aligns with the software requirements. | ( ) Yes ( ) Needs Improvement: |
| All software systems are identified, and their respective safety classifications are indicated. | ( ) Yes ( ) Needs Improvement: |
| The software components are clearly listed and described, including their interfaces. | ( ) Yes ( ) Needs Improvement: |
| All software units are listed and explained. | ( ) Yes ( ) Needs Improvement: |
| (Optional) Additional architecture details are provided, such as databases, security, and data protection. | ( ) Yes ( ) Needs Improvement: |
| The architecture can be implemented with the available resources. | ( ) Yes ( ) Needs Improvement: |
2. Comments
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3. Evaluation Outcome
( ) Software Architecture approved\
( ) Software Architecture not approved\
( ) Software Architecture approved with the following conditions: \