# IEC 62304 Class C Requirements Management MCP Server

A Model Context Protocol (MCP) server for managing software requirements in compliance with IEC 62304 Class C medical device software standards.

## Features

- ✅ Full IEC 62304 Class C compliance
- 📋 Software requirement management with versioning
- 🔗 Complete traceability matrix generation
- 📊 Requirements dashboard and statistics
- 📝 Automated SRS document generation
- 🔒 Risk management integration (ISO 14971)
- 📚 Comprehensive audit trail

## Installation
```bash
# Clone or create project directory
mkdir iec62304-mcp-requirements
cd iec62304-mcp-requirements

# Install with uv
uv sync
```

## Usage with Claude Desktop

1. Add to Claude Desktop config (`~/Library/Application Support/Claude/claude_desktop_config.json` on Mac):
```json
{
  "mcpServers": {
    "iec62304-requirements": {
      "command": "uv",
      "args": [
        "--directory",
        "/path/to/iec62304-mcp-requirements",
        "run",
        "src/server.py"
      ]
    }
  }
}
```

2. Restart Claude Desktop

## Available Tools

- `create_requirement` - Create new software requirement
- `get_requirement` - Retrieve requirement details
- `update_requirement` - Update with version control
- `get_requirement_history` - View version history
- `create_traceability_link` - Link requirements to other artifacts
- `search_requirements` - Search and filter requirements
- `generate_traceability_matrix` - Export traceability matrix
- `generate_srs_document` - Generate SRS documentation
- `get_dashboard_statistics` - View requirements statistics
- `create_risk_control` - Create risk control with linkage

## IEC 62304 Compliance

This tool implements:
- Section 5.1.1: Requirements traceability
- Section 5.2: Software requirements analysis
- Section 8: Configuration management
- ISO 14971 risk management integration

## License

MIT License