ISO 13485 (Clause 8.4) - Periodic Safety Update Report

Maintain a proactive approach to safety monitoring and regulatory compliance with our ISO 13485:2016 Clause 8.4 Periodic Safety Update Report Template. Regular safety updates are essential for ensuring that your medical devices continue to meet safety and performance standards throughout their lifecycle. This ready-to-use template provides a structured framework for compiling and documenting periodic safety updates, ensuring compliance with ISO 13485:2016 requirements and supporting ongoing post-market surveillance efforts.

✔ Pre-Formatted Periodic Safety Update Report – Fully aligned with ISO 13485:2016 Clause 8.4 requirements.
✔ Safety Data Collection & Analysis – Define procedures for collecting and analyzing post-market safety data from adverse events, customer feedback, and performance reviews.
✔ Risk Assessment & Evaluation – Identify and assess any emerging safety concerns or risks related to your device.
✔ Safety and Performance Reporting – Prepare comprehensive reports on device performance and safety for regulatory authorities.
✔ Corrective and Preventive Actions (CAPA) – Document actions taken to mitigate safety issues and prevent recurrence.
✔ Audit-Ready Documentation – Keep well-organized records for internal audits and regulatory inspections.
✔ Editable Digital Format – Fully customizable for various medical device types.

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

Download the ISO 13485:2016 Periodic Safety Update Report Template today and enhance your post-market safety compliance!