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