ISO 13485 (Clause 8.4) - Monitoring, Measurement & Post Market Activities Procedure (Class I)

Ensure effective monitoring, measurement, and post-market activities for Class I medical devices with our ISO 13485:2016 Clause 8.4 Procedure Template. Proper management of post-market surveillance and measurement activities is crucial for maintaining product quality and ensuring compliance with ISO 13485:2016. This ready-to-use template provides a structured framework for monitoring and measuring product performance in the field, managing customer feedback, and implementing corrective actions for Class I devices, ensuring regulatory compliance and continuous improvement.

✔ Pre-Formatted Monitoring, Measurement & Post-Market Activities Procedure – Covers key ISO 13485:2016 Clause 8.4 requirements for Class I medical devices.
✔ Post-Market Surveillance Guidelines – Track device performance, adverse events, and complaints from customers.
✔ Measurement & Performance Tracking – Define criteria and methods for monitoring device performance in real-world conditions.
✔ Customer Feedback & Complaint Management – Capture and assess feedback and complaints to identify areas for improvement.
✔ Corrective & Preventive Action (CAPA) Integration – Ensure corrective actions are taken based on post-market data.
✔ Audit-Ready Documentation & Compliance Tracking – Maintain structured records for internal audits and regulatory inspections.
✔ Editable Digital Format – Fully customizable for various Class I devices and business needs.

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

Download the ISO 13485:2016 Monitoring, Measurement & Post-Market Activities Procedure (Class I) Template today and improve your post-market surveillance and quality management system!