REQUIREMENTS ENGINEERING
Medical Device Software Requirements and Automated Verification Test ER Diagram
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CASE ANALYSIS
Scenario
A medical device software team must maintain traceability from design input requirements to automated verification test cases and test execution results to support regulatory submissions.
Key decisions
- Introduced RequirementTestTrace entity to model many-to-many relationships between requirements and test cases.
- Separated TestCase from TestResult to retain test definition history across executions.
- Linked automation scripts to test cases to distinguish manual vs automated verification.
When to reuse this
Use when modeling data for requirements management and automated test execution with regulatory traceability needs.
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