Medical Device Risk Management Plan - ISO 14971

Develop a structured and compliant risk management process with our ISO 14971:2019 Risk Management Plan Template. A well-defined risk management plan is essential for ensuring that medical devices meet safety and regulatory requirements throughout their lifecycle. This template provides a systematic approach to risk management, ensuring compliance with ISO 14971:2019, ISO 13485:2016, MDR, IVDR, and FDA 21 CFR Part 820.

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

✔ Scope & Objectives Definition – Establish the purpose, regulatory requirements, and scope of risk management activities.

✔ Roles & Responsibilities Assignment – Define who is responsible for risk management activities and decision-making.

✔ Risk Identification & Assessment Criteria – Outline methods for identifying, analyzing, and evaluating risks.

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

✔ Residual Risk Evaluation & Acceptance Criteria – Ensure risks are within acceptable safety thresholds.

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

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

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

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

Download the ISO 14971:2019 Risk Management Plan Template today and strengthen your risk management and regulatory compliance strategy!