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