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Risk Management Plan

1.1 Test risk

This section defines the structured plan for applying ISO 14971 risk management throughout the lifecycle of CardioMonitor Pro ECG-12. (Placeholder – to be expanded with project‑specific planning details.).

1. Objectives

  • Ensure systematic identification, evaluation, control, and monitoring of risks.
  • Maintain documented evidence of decision rationale and residual risk acceptability.

2. Deliverables

Phase Deliverable Reference
Planning Approved Risk Management Plan This document
Analysis Hazard & risk tables RM File Section 4/5
Control Implemented control list RM File Section 6
Evaluation Residual risk summary RM File Section 7
Reporting Risk Management Report RM File Section 8

3. Methods & Tools

Method Purpose Tool / Artifact
Hazard analysis Identify sources of harm Structured checklist
FMEA elements Assess failure modes Worksheet (internal)
Risk matrix Classification Defined scoring table
Traceability Link risk ↔ control ↔ test Traceability Matrix
PMS review Post‑market signals PMS reports

4. Review & Update Frequency

  • Design phase: at each major milestone.
  • Post‑market: quarterly surveillance review.
  • Trigger-based updates: design changes, new hazards, regulatory shifts.

5. Escalation Criteria

  • Emergence of an unanticipated serious risk.
  • Increase in frequency pushing a score ≥9.
  • Regulatory notice or field safety corrective action (FSCA).

6. Documentation Control

All revisions tracked via change history and versioned using repository + metadata automation.

7. Annexes

Annex A: Change History

Date Version Author Changes
19. November 2025 1 Unbekannt feat: Add CI/CD workflow for building, deploying, and individual PDF generation, and include a new Risk Management Plan document.

See Also