Software vv test generator

Skill a5c-ai/babysitter/library/specializations/domains/science/biomedical-engineering/skills/software-vv-test-generator

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Medical device software verification and validation test case generation skill

SKILL.md

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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