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

Ensure effective monitoring, measurement, and post-market activities for Class II and higher medical devices with our ISO 13485:2016 Clause 8.4 Procedure Template. Proper management of post-market surveillance, measurement systems, and ongoing monitoring is critical for ensuring product quality, patient safety, and regulatory compliance for higher-risk devices. This ready-to-use template provides a comprehensive, structured framework for assessing device performance, monitoring safety, and gathering customer feedback for Class II+ devices, in full alignment with ISO 13485:2016 requirements.

✔ Pre-Formatted Monitoring, Measurement & Post-Market Activities Procedure – Covers key ISO 13485:2016 Clause 8.4 requirements for Class II+ medical devices.
✔ Post-Market Surveillance Framework – Track adverse events, device performance, and safety concerns from end-users and healthcare professionals.
✔ Measurement System Validation & Performance Tracking – Establish methods for evaluating product performance and measurement consistency.
✔ Customer Feedback & Complaint Management – Implement systems to capture, assess, and resolve complaints to mitigate risks.
✔ Risk Management & CAPA Integration – Ensure corrective and preventive actions are implemented based on post-market data.
✔ Audit-Ready Documentation – Keep comprehensive records for internal audits and regulatory inspections.
✔ Editable Digital Format – Fully customizable for various device types and regulatory requirements.

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

Download the ISO 13485:2016 Monitoring, Measurement & Post-Market Activities Procedure (Class II+) Template today and enhance your post-market surveillance and quality assurance efforts!