Software V&V Test Generator Skill
Purpose
The Software V&V Test Generator Skill creates comprehensive verification and validation test cases for medical device software, ensuring requirements coverage and regulatory compliance.
Capabilities
- Requirements-based test case derivation
- Unit test framework setup (embedded and application)
- Integration test planning
- System test protocol generation
- Test coverage analysis (statement, branch, MC/DC)
- Traceability matrix generation
- Test report templates
- Boundary value analysis
- Equivalence partitioning
- Negative testing scenarios
- Regression test suite management
Usage Guidelines
When to Use
- Developing software test strategies
- Creating test cases from requirements
- Analyzing test coverage
- Preparing V&V documentation
Prerequisites
- Software requirements documented
- Safety classification determined
- Test environment defined
- Acceptance criteria established
Best Practices
- Achieve coverage appropriate for safety class
- Test both normal and abnormal conditions
- Maintain traceability to requirements
- Automate regression testing
Process Integration
This skill integrates with the following processes:
- Software Verification and Validation
- Software Development Lifecycle (IEC 62304)
- AI/ML Medical Device Development
- Design Control Process Implementation
Dependencies
- pytest, GoogleTest frameworks
- LDRA, VectorCAST tools
- Test management systems
- Coverage analysis tools
- CI/CD pipelines
Configuration
software-vv-test-generator:
test-levels:
- unit
- integration
- system
- acceptance
coverage-metrics:
- statement
- branch
- MC-DC
- condition
test-types:
- functional
- boundary
- negative
- stress
- performance
Output Artifacts
- Test case specifications
- Test procedures
- Test scripts/automation
- Coverage reports
- Traceability matrices
- Test summary reports
- Defect reports
- Regression test suites
Quality Criteria
- Test cases traceable to requirements
- Coverage meets safety class requirements
- Boundary conditions tested
- Negative scenarios included
- Automation maximized
- Reports support regulatory submission