Medical Device Risk Identification, Analysis and Control - ISO 14971

Streamline your risk management process with our ISO 14971:2019 Risk Identification, Analysis & Control Spreadsheet Template. Identifying, analyzing, and controlling risks is essential for ensuring the safety, effectiveness, and regulatory compliance of medical devices. This structured spreadsheet template provides a systematic approach for tracking and managing risks throughout the product lifecycle, ensuring compliance with ISO 14971:2019, ISO 13485:2016, MDR, IVDR, and FDA 21 CFR Part 820.

✔ Pre-Formatted Risk Management Spreadsheet – Covers key ISO 14971:2019 risk management requirements.

✔ Risk Identification & Hazard Categorization – Document potential device-related hazards and failure modes.

✔ Risk Analysis & Evaluation – Assess risks based on severity, probability, and detectability scoring.

✔ Risk Control Measures & Mitigation Strategies – Define preventive actions and risk reduction plans.

✔ Residual Risk Assessment & Benefit-Risk Justification – Ensure risks meet acceptable safety thresholds.

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

✔ Audit-Ready Documentation & Traceability – Maintain structured records for regulatory inspections.

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

This risk management spreadsheet is ideal for regulatory teams, risk managers, and quality professionals, ensuring a structured, compliant, and effective approach to risk management.

Download the ISO 14971:2019 Risk Identification, Analysis & Control Spreadsheet Template today and enhance your medical device safety strategy!