Agent skill

software-vv-test-generator

Medical device software verification and validation test case generation skill

Stars 514
Forks 31

Install this agent skill to your Project

npx add-skill https://github.com/a5c-ai/babysitter/tree/main/library/specializations/domains/science/biomedical-engineering/skills/software-vv-test-generator

Metadata

Additional technical details for this skill

domain
science
category
Medical Device Software
skill id
BME-SK-020
specialization
biomedical-engineering

SKILL.md

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

yaml
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

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