Risk Evaluation and Risk-Benefit Report - ISO 14971

Demonstrate regulatory compliance and patient safety with our ISO 14971:2019 Risk-Benefit Report Template. A comprehensive risk-benefit analysis is essential for ensuring that the benefits of a medical device outweigh its potential risks, aligning with ISO 14971:2019, MDR, IVDR, FDA 21 CFR Part 820, and ISO 13485:2016. This structured template provides a systematic approach to evaluating risk-benefit factors, helping manufacturers ensure regulatory approval and market acceptance.

✔ Pre-Formatted Risk-Benefit Report Template – Covers key ISO 14971:2019 requirements.

✔ Risk Identification & Assessment Framework – Document potential hazards and associated risks.

✔ Benefit Analysis & Clinical Justification – Provide evidence supporting device effectiveness and patient benefit.

✔ Residual Risk Evaluation & Acceptance Criteria – Ensure compliance with risk acceptability thresholds.

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

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

✔ Approval & Sign-Off Workflow – Assign responsibility for risk-benefit validation and compliance tracking.

✔ Editable Digital Format – Fully customizable for different medical device classifications and risk levels.

This risk-benefit report template is ideal for regulatory teams, risk managers, and quality professionals, ensuring a structured, compliant, and well-documented risk-benefit analysis.

Download the ISO 14971:2019 Risk-Benefit Report Template today and strengthen your risk management and regulatory compliance strategy!