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
# Clone or create project directory
mkdir iec62304-mcp-requirements
cd iec62304-mcp-requirements
# Install with uv
uv syncUsage with Claude Desktop
- Add to Claude Desktop config (
~/Library/Application Support/Claude/claude_desktop_config.jsonon Mac):
{
"mcpServers": {
"iec62304-requirements": {
"command": "uv",
"args": [
"--directory",
"/path/to/iec62304-mcp-requirements",
"run",
"src/server.py"
]
}
}
}- Restart Claude Desktop
Available Tools
create_requirement- Create new software requirementget_requirement- Retrieve requirement detailsupdate_requirement- Update with version controlget_requirement_history- View version historycreate_traceability_link- Link requirements to other artifactssearch_requirements- Search and filter requirementsgenerate_traceability_matrix- Export traceability matrixgenerate_srs_document- Generate SRS documentationget_dashboard_statistics- View requirements statisticscreate_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
