Medical Device Risk Management ISO 14971 checklist

Streamline your risk management process with our ISO 14971:2019 Risk Management Checklist Template. Risk management is essential for ensuring the safety and effectiveness of medical devices while maintaining compliance with ISO 14971:2019, ISO 13485:2016, MDR, IVDR, and FDA 21 CFR Part 820. This comprehensive checklist helps organizations systematically identify, assess, control, and monitor risks throughout the medical device lifecycle, ensuring full regulatory compliance and traceability.

✔ Pre-Formatted ISO 14971:2019 Checklist – Covers key risk management requirements from hazard identification to risk control.

✔ Risk Identification & Hazard Assessment – Systematically evaluate potential device-related hazards.

✔ Risk Analysis, Evaluation & Acceptance Criteria – Ensure risks are assessed using severity, probability, and detectability.

✔ Risk Control Measures & Effectiveness Assessment – Define mitigation strategies and residual risk evaluations.

✔ Post-Market Surveillance & Risk Monitoring – Align with MDR & IVDR post-market risk management requirements.

✔ Traceability & Documentation Compliance – Maintain audit-ready risk records for regulatory inspections.

✔ Editable Digital Format – Fully customizable for various medical device classifications and risk management needs.

This ISO 14971:2019 checklist is ideal for quality managers, risk assessment teams, and regulatory professionals, ensuring a structured, compliant, and effective risk management system.

Download the ISO 14971:2019 Risk Management Checklist Template today and strengthen your medical device safety and compliance strategy!