ISO 13485 (Clause 8.4) - Post Market Surveillance Report

Maintain continuous product safety, performance monitoring, and regulatory compliance with our ISO 13485:2016 Clause 8.4 Post-Market Surveillance Report Template. Post-market surveillance is critical for tracking medical device performance after it has been released to the market. This ready-to-use template helps you structure and document post-market data effectively, ensuring ongoing compliance with ISO 13485:2016 requirements and providing a solid foundation for corrective actions and continuous improvement.

✔ Pre-Formatted Post-Market Surveillance Report – Covers key ISO 13485:2016 Clause 8.4 requirements.
✔ Post-Market Data Collection – Define methods for collecting safety, performance, and quality data from various sources, including user feedback, complaints, and adverse events.
✔ Risk Evaluation & Assessment – Evaluate potential risks and safety issues related to the device’s ongoing use.
✔ Trend Analysis & Reporting – Track trends in performance data and document any required regulatory notifications.
✔ Corrective & Preventive Actions (CAPA) – Ensure necessary actions are taken based on post-market findings.
✔ Audit-Ready Documentation – Maintain structured records for audits and regulatory inspections.
✔ Editable Digital Format – Fully customizable for various device types and market requirements.

This post-market surveillance report template is ideal for quality managers, regulatory affairs teams, and compliance officers, ensuring a compliant, structured approach to post-market activities.

Download the ISO 13485:2016 Post-Market Surveillance Report Template today and enhance your product safety and regulatory compliance!