IEC 62304 Requirements 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

# 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):

{
  "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