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IEC 62304 Requirements MCP Server

IEC 62304 Requirements MCP Server

by Pakawat-Dev
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Python
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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

Related MCP server: eazy-ba

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"
      ]
    }
  }
}

  1. 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

Available Tools

10 tools
create_requirementA

Create a new software requirement (IEC 62304 Section 5.2.2)

Args: req_id: Unique requirement ID (e.g., SWR-001) title: Short descriptive title (10-200 chars) description: Detailed requirement description (min 20 chars) category: functional, performance, interface, safety, security, usability priority: critical, high, medium, low created_by: Name of person creating requirement safety_classification: class_a, class_b, or class_c (default: class_c) rationale: Justification for the requirement (optional) acceptance_criteria: Verification criteria (optional)

Returns: Success message with requirement ID

Example: create_requirement( req_id="SWR-001", title="User Authentication Required", description="The system shall authenticate users using bcrypt algorithm with minimum 12 rounds before granting access to patient data", category="security", priority="critical", created_by="John Doe", rationale="Required for HIPAA compliance" )

Inputs: title (required), req_id (required), category (required), priority (required), +5 more. Returns: result

create_risk_controlA

Create risk control with requirement linkage (ISO 14971 integration)

Args: risk_id: Unique risk ID (e.g., RK-001) hazard_description: Description of the hazard severity: Catastrophic, Critical, Marginal, or Negligible probability: Frequent, Probable, Occasional, Remote, or Improbable control_measures: Risk mitigation measures description requirement_id: Linked requirement ID (optional)

Returns: Success message with risk ID and calculated risk level

Inputs: risk_id (required), severity (required), probability (required), control_measures (required), +2 more. Returns: result

create_traceability_linkA

Create traceability link (IEC 62304 Section 5.1.1)

Args: source_id: Source artifact ID (e.g., SWR-001) source_type: requirement, design, test, or risk target_id: Target artifact ID (e.g., DESIGN-001) target_type: requirement, design, test, or risk link_type: derives_from, implements, verifies, mitigates, or relates_to description: Optional link description

Returns: Success message with link ID

Example: create_traceability_link( source_id="SWR-001", source_type="requirement", target_id="DESIGN-AUTH-001", target_type="design", link_type="implements" )

Inputs: link_type (required), source_id (required), target_id (required), source_type (required), +2 more. Returns: result

generate_srs_documentA

Generate Software Requirements Specification (IEC 62304 Section 5.2.6)

Args: export_path: File path for SRS document (default: docs/SRS_Document.md)

Returns: Success message with file path

Inputs: export_path. Returns: result

generate_traceability_matrixA

Generate complete traceability matrix (IEC 62304 Section 5.1.1)

Args: export_path: File path for CSV export (default: docs/traceability_matrix.csv)

Returns: Success message with file path

Inputs: export_path. Returns: result

get_dashboard_statisticsA

Get requirements dashboard statistics

Returns: Formatted statistics summary including counts by status, category, and traceability coverage

Inputs: no named parameters. Returns: result

get_requirementA

Retrieve a requirement by ID

Args: req_id: Requirement ID (e.g., SWR-001)

Returns: Formatted requirement details including traceability links

Inputs: req_id (required). Returns: result

get_requirement_historyA

Get complete version history (IEC 62304 Section 8.1.2)

Args: req_id: Requirement ID

Returns: Formatted version history with all changes

Inputs: req_id (required). Returns: result

search_requirementsA

Search and filter requirements

Args: status: Filter by status - draft, reviewed, approved, implemented, verified (optional) category: Filter by category - functional, performance, interface, safety, security, usability (optional) safety_class: Filter by safety classification - class_a, class_b, class_c (optional) search_text: Search in title and description (optional)

Returns: List of matching requirements

Inputs: status, category, search_text, safety_class. Returns: result

update_requirementA

Update requirement with version control (IEC 62304 Section 8)

Args: req_id: Requirement ID to update changed_by: Name of person making change change_reason: Reason for the change (required for audit) title: New title (optional) description: New description (optional) status: New status - draft, reviewed, approved, implemented, verified (optional) priority: New priority - critical, high, medium, low (optional)

Returns: Success message with new version number

Inputs: req_id (required), changed_by (required), change_reason (required), title, +3 more. Returns: result

Tool Schema Changelog

Recent tool additions, removals, and schema changes observed during successful MCP inspections.

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    Deploy Server
    One endpoint for every MCP toolRayrun runs every MCP server behind one URL and holds the credentials. Each call is decided per client, tool, and argument, then recorded.ray.runAd

    TDQS

    A4.1/5.0

    Scored across 10 tools

    Disambiguation5/5

    Each tool targets a distinct operation: requirement CRUD/history, traceability link creation and matrix generation, SRS export, dashboard stats, and risk control creation. There is no meaningful overlap in purpose, and the argument names reinforce the boundaries.

    Naming Consistency5/5

    All tools follow the same snake_case verb_noun pattern (create_requirement, get_requirement_history, generate_srs_document). The consistency makes the action and resource predictable across the entire server.

    Tool Count5/5

    Ten tools is well-scoped for an IEC 62304 requirements management server, covering creation, retrieval, update, history, search, traceability, export, dashboard, and risk control. No tool feels redundant or unnecessary, and the count stays within the ideal range.

    Completeness4/5

    Core requirement lifecycle and traceability workflows are covered, including versioned updates, history, matrix generation, and SRS export. Minor gaps exist for deletion/obsoletion of requirements and full risk-control management (only create_risk_control is provided), but these are workable within the stated regulatory context.

    Maintenance

    ActivityInactive
    ResponsivenessNo recent community issues

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