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software-vv-test-generator skill

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This skill helps you generate comprehensive medical device software verification and validation test cases aligned to requirements and regulatory standards.

npx playbooks add skill a5c-ai/babysitter --skill software-vv-test-generator

Review the files below or copy the command above to add this skill to your agents.

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SKILL.md
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---
name: software-vv-test-generator
description: Medical device software verification and validation test case generation skill
allowed-tools:
  - Read
  - Write
  - Glob
  - Grep
  - Edit
  - Bash
metadata:
  specialization: biomedical-engineering
  domain: science
  category: Medical Device Software
  skill-id: BME-SK-020
---

# 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

Overview

This skill generates comprehensive verification and validation (V&V) test cases tailored for medical device software, with a focus on requirement coverage and regulatory readiness. It produces test artifacts and plans across unit, integration, system, and acceptance levels to support IEC 62304 and design control processes. The outputs are designed to integrate with CI/CD, test management, and coverage analysis tools.

How this skill works

The skill analyzes documented software requirements and safety classification to derive requirements-based test cases, including boundary value, equivalence partitioning, and negative scenarios. It creates unit test scaffolding, integration plans, system test protocols, traceability matrices, and coverage targets (statement, branch, MC/DC). It can generate templates and automation-ready scripts for pytest or GoogleTest and produces test summary and defect report formats for regulatory submission.

When to use it

  • Designing a V&V strategy for medical device software
  • Converting requirements into traceable test cases
  • Preparing coverage analysis and MC/DC evidence
  • Building regression suites and automation for releases
  • Assembling V&V documentation for regulatory review
  • Planning tests for AI/ML components in devices

Best practices

  • Establish and document acceptance criteria and safety class before test design
  • Ensure every test case maps to one or more requirements via a traceability matrix
  • Include normal, boundary, and abnormal (negative) conditions for each feature
  • Target coverage metrics appropriate to the device safety class (MC/DC where required)
  • Automate regression suites and integrate them into CI/CD pipelines

Example use cases

  • Generate unit and integration test scaffolding for embedded firmware using GoogleTest or pytest
  • Produce system test protocols and pass/fail criteria for a software release package
  • Create a requirements-to-test traceability matrix and coverage report for IEC 62304 submission
  • Design negative and boundary test suites for a patient monitoring feature
  • Assemble regression test suites and automation templates for continuous verification

FAQ

What inputs does the skill require?

Documented software requirements, determined safety classification, defined test environment, and acceptance criteria are required to generate meaningful test cases.

Which coverage metrics are supported?

Statement, branch, condition, and MC/DC coverage metrics are supported; select metrics based on safety class and regulatory needs.

Can it produce runnable test scripts?

Yes. The skill can output test scripts and scaffolding compatible with frameworks like pytest and GoogleTest, ready for integration with CI/CD and test management tools.