Risk Management Procedure Template - ISO 13485

This risk management procedure template is ideal for quality managers, regulatory teams, and compliance officers, ensuring a structured, compliant, and efficient risk management system.

Download the ISO 13485:2016 Risk Management Procedure Template today and strengthen your quality and compliance strategy!

✔ Pre-Formatted Risk Management Procedure – Covers all ISO 13485:2016 Clause 7.1 requirements.

✔ Risk Identification & Assessment Framework – Define how to identify and assess risks related to design, manufacturing, and post-market.

✔ Risk Control & Mitigation Strategies – Establish effective controls and measures to reduce or eliminate risks.

✔ Risk Evaluation & Acceptance Criteria – Set risk acceptance thresholds and evaluate residual risks.

✔ Risk Management Documentation & Records – Ensure structured documentation of risk assessments and control actions.

✔ Integration with Design & Development Process – Embed risk management into product development, manufacturing, and service stages.

✔ Audit-Ready Compliance Tracking – Maintain records for regulatory inspections and internal audits.

✔ Editable Digital Format – Fully customizable for various medical device types and risk levels.

Ensure a structured and compliant risk management process with our ISO 13485:2016 Clause 7.1 Risk Management Procedure Template. Managing risk is crucial in the medical device industry to ensure product safety, effectiveness, and regulatory compliance. This ready-to-use procedure template provides a systematic approach to identifying, assessing, and mitigating risks throughout the product lifecycle, ensuring full compliance with ISO 13485:2016 and relevant regulatory standards.