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" )

Retrieve a requirement by ID

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

Returns: Formatted requirement details including traceability links

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

Get complete version history (IEC 62304 Section 8.1.2)

Args: req_id: Requirement ID

Returns: Formatted version history with all changes

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" )

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

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

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

Get requirements dashboard statistics

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

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