ISO 13485 (Clause 8.4) - Post Market Clinical Follow Up (PMCF) Report

Ensure ongoing clinical safety and regulatory compliance with our ISO 13485:2016 Clause 8.4 Post-Market Clinical Follow-Up Report Template. Post-market clinical follow-ups are essential for monitoring the safety and performance of medical devices after they are released to the market. This ready-to-use template provides a structured framework for documenting clinical follow-up data, tracking product performance, and ensuring compliance with ISO 13485:2016 while supporting continuous improvement.

✔ Pre-Formatted Post-Market Clinical Follow-Up Report – Covers key ISO 13485:2016 Clause 8.4 requirements for documenting follow-up activities.
✔ Clinical Data Overview – Summarize clinical performance, safety outcomes, and patient feedback gathered during post-market surveillance.
✔ Risk Assessment & Impact Evaluation – Assess risks, adverse events, and any safety concerns identified in clinical use.
✔ Corrective Actions & Preventive Measures – Document corrective actions taken based on clinical findings and any preventive measures for future improvement.
✔ Regulatory Reporting Compliance – Ensure the report aligns with regulatory authorities’ requirements for post-market clinical follow-up.
✔ Audit-Ready Documentation – Maintain structured records for audits, inspections, and regulatory reviews.
✔ Editable Digital Format – Fully customizable for various device types and clinical follow-up needs.

This post-market clinical follow-up report template is ideal for regulatory affairs teams, quality managers, and compliance officers, ensuring a compliant, efficient approach to post-market clinical monitoring.

Download the ISO 13485:2016 Post-Market Clinical Follow-Up Report Template today to enhance your product safety monitoring and regulatory compliance!