---
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
graph:
  domains: [domain:biomedical-engineering]
  skillAreas: [skill-area:statistical-analysis, skill-area:data-analysis, skill-area:compliance-automation]
  workflows: [workflow:experiment-design, workflow:peer-review-cycle]
  roles: [role:biomedical-engineer, role:qa-engineer]
---

# 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


---
Source attribution: a5c-ai
Original project: https://github.com/a5c-ai/babysitter
License: MIT
License information: https://opensource.org/license/mit
Original upstream instructions; downloaded from Mega AI Hub.

## Upstream license notice

MIT License

Copyright (c) 2026 Gabriel Moreira

Permission is hereby granted, free of charge, to any person obtaining a copy
of this software and associated documentation files (the "Software"), to deal
in the Software without restriction, including without limitation the rights
to use, copy, modify, merge, publish, distribute, sublicense, and/or sell
copies of the Software, and to permit persons to whom the Software is
furnished to do so, subject to the following conditions:

The above copyright notice and this permission notice shall be included in all
copies or substantial portions of the Software.

THE SOFTWARE IS PROVIDED "AS IS", WITHOUT WARRANTY OF ANY KIND, EXPRESS OR
IMPLIED, INCLUDING BUT NOT LIMITED TO THE WARRANTIES OF MERCHANTABILITY,
FITNESS FOR A PARTICULAR PURPOSE AND NONINFRINGEMENT. IN NO EVENT SHALL THE
AUTHORS OR COPYRIGHT HOLDERS BE LIABLE FOR ANY CLAIM, DAMAGES OR OTHER
LIABILITY, WHETHER IN AN ACTION OF CONTRACT, TORT OR OTHERWISE, ARISING FROM,
OUT OF OR IN CONNECTION WITH THE SOFTWARE OR THE USE OR OTHER DEALINGS IN THE
SOFTWARE.



# Mega AI Hub resource metadata

Creator / publisher: a5c-ai
Original project: https://github.com/a5c-ai/babysitter
Attribution basis: Upstream repository explicitly recorded in package mirror path

Fields of work: Data & Analytics, Development & Engineering, Healthcare & Life Sciences, Product Management
Roles: Business Intelligence Analyst, Clinical Research, Medical Writer, Product Manager, QA / Test Engineer
Specialties: Testing
Tools: Ldra, Vectorcast
Country applicability: Country not specified
Classification basis: Source catalog labels
Instruction SHA-256: c0b6400173cd33d2b072cd54b9b314985b5e8246f6f3970699285287dda10316