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Traceability Matrix (IEC 62304 / ISO 14971) – CardioMonitor Pro ECG-12

  • Document: Traceability Matrix
  • Product: CardioMonitor Pro ECG-12
  • Version: 1.1.0

  • Gültig ab: 17. November 2025- Erstellungsdatum: 17. November 2025- Letzte Überarbeitung: 17. November 2025- Creation Date: November 16, 2025

  • Letzte Überarbeitung: 19. November 2025- Last Revision: November 16, 2025

  • Nächste Überprüfung: 19. November 2026- Next Review: November 16, 2026

  • Approved by: [QA Responsible]
  • Responsible: [Traceability Coordinator]

1 Purpose

Ensuring complete traceability from Risks → Requirements → Architecture Elements → Implementation → Test Cases → Verification/Release.

2 Structure & Conventions

  • Risk IDs: R### (see 20.01_risk_management_file.md)
  • Software Requirements: SR-### (see SRS)
  • Architecture Items: SI-XXX (see Architecture)
  • Implementation Reference: Module / File / Commit Hash
  • Test Cases: TC-###

3 Matrix Overview (Excerpt)

Risk-ID Hazard SR-ID Software-Item Measure / Arch. Concept Test Case-ID Implementation Reference Status
R001 Electric Shock SR-013 SI-SEC Watchdog / Integrity Check TC-040 watchdog.c / commit pqr678 Open
R002 Misdiagnosis SR-001 SI-ANALYSIS Validated Algorithm + Redundancy TC-001, TC-002 analysis_module.py / commit abc123 Open
R002 Misdiagnosis SR-002 SI-SIGNAL Signal quality check before analysis TC-010 signal_quality.py / commit def456 Open
R002 Misdiagnosis SR-005 SI-UI Warning notice for uncertain analysis TC-030 ui_alerts.js / commit mno345 Open
R002 Misdiagnosis SR-001 SI-ANALYSIS Validated Algorithm + Redundancy TC-001, TC-002 analysis_module.py / commit abc123 Open
R002 Misdiagnosis SR-002 SI-SIGNAL Signal quality check before analysis TC-010 signal_quality.py / commit def456 Open
R002 Misdiagnosis SR-005 SI-UI Warning notice for uncertain analysis TC-030 ui_alerts.js / commit mno345 Open
R002 Misdiagnosis SR-013 Open
R003 Cross-Infection Open
R004 Data Loss SR-003 Open
R004 Data Loss SR-004 Open
R004 Data Loss SR-003 Open
R005 Allergic Reaction Open
R006 Overheating Open
R007 Mechanical Injury Open
R008 Privacy Breach Open
R009 Battery Failure Open
R010 Wrong Patient Assignment Open
R011 Electromagnetic Interference Open
R012 Software Crash Open
R013 Printer Error Open
R014 Display Failure Open
R015 Cable Break Open
R016 Condensation Open
R017 Electrode Detachment Open
R018 Incorrect Calibration Open
R019 Virus Infection (IT) Open
R020 Device Falling Over Open
R021 User Error Open
R022 Alarm Failure Open
R023 Memory Overflow Open
R024 Network Interruption Open
R025 Time Error Open

Legend Status: Open / Implemented / Verified / Released.

4 Gap Analysis (Initial)

Category Count Comment
Risks without SR assignment 0 Initially only R001,R002,R005 recorded
SR without Risk (purely functional) 2 Convenience functions (SR-006 etc.)
SR without Test Case 0 Test case IDs planned, implementation follows
Test Cases without Implementation 6 In Planning

5 Maintenance Process

  • QA updates matrix after each sprint / release review.
  • New risks → Reconciliation, addition of SR or measure.
  • Automated export possible (later CI step) for consistency check.

6 Change Tracking

Each change to risk, requirement, or test case triggers matrix update. Document version via metadata script.

7 Extension Options (Planned)

  • Linking test automation reports
  • Coverage calculation (percent implemented / verified)
  • Automatic extraction from code comments (tags: @SR-001, @R002)

8 Annexes

Annex A: Change History

Date Version Author Changes
19. November 2025 1.1.0 Unbekannt Automatische Metadatenaktualisierung
17. November 2025 1.0.1 Unbekannt Automatische Metadatenaktualisierung

See Also