ISO 13485 (Clause 8.4) - Periodic Safety Update Plan

Ensure ongoing product safety and regulatory compliance with our ISO 13485:2016 Clause 8.4 Periodic Safety Update Plan Template. Regular safety updates are critical for maintaining the safety and performance of medical devices throughout their lifecycle, especially for devices that are already on the market. This ready-to-use template provides a comprehensive, structured plan for performing periodic safety updates, ensuring your organization remains compliant with ISO 13485:2016 requirements and proactively addresses safety concerns.

✔ Pre-Formatted Periodic Safety Update Plan – Covers key ISO 13485:2016 Clause 8.4 requirements.
✔ Safety Data Collection & Evaluation – Define procedures for collecting and evaluating post-market safety data from various sources, such as user feedback and adverse events.
✔ Risk Management Integration – Align the periodic safety review with ongoing risk management activities to mitigate safety concerns.
✔ Safety and Performance Reporting – Establish a process for reporting the safety status and performance data to regulatory bodies.
✔ Corrective Actions & Risk Mitigation – Ensure corrective actions and preventive measures are taken based on safety findings.
✔ Audit-Ready Documentation – Maintain structured records for regulatory inspections and internal audits.
✔ Editable Digital Format – Fully customizable for various device types and regulatory requirements.

This safety update plan template is ideal for quality managers, regulatory affairs teams, and compliance officers, ensuring a compliant, structured approach to safety monitoring.

Download the ISO 13485:2016 Periodic Safety Update Plan Template today to enhance your post-market surveillance and regulatory compliance efforts!