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

Ensure continuous clinical safety and performance monitoring with our ISO 13485:2016 Clause 8.4 Post-Market Clinical Follow-Up Plan Template. Post-market surveillance of medical devices is critical for ensuring that your products maintain safety, quality, and regulatory compliance throughout their lifecycle. This ready-to-use template provides a comprehensive plan for conducting post-market clinical follow-ups, ensuring compliance with ISO 13485:2016 and improving device performance based on real-world data.

✔ Pre-Formatted Post-Market Clinical Follow-Up Plan – Aligned with ISO 13485:2016 Clause 8.4 requirements.
✔ Clinical Data Collection Methods – Define procedures for gathering real-world clinical data, including patient outcomes, adverse events, and safety concerns.
✔ Follow-Up Monitoring & Evaluation – Track the safety and effectiveness of your device in a clinical setting.
✔ Risk Management & Reporting – Identify and assess risks and ensure corrective actions are implemented.
✔ Regulatory Compliance & Reporting Requirements – Ensure compliance with regulatory authorities by documenting follow-up activities and outcomes.
✔ Continuous Improvement Integration – Use clinical follow-up data to drive ongoing product improvements.
✔ Audit-Ready Documentation – Keep structured records for internal audits and regulatory inspections.
✔ Editable Digital Format – Fully customizable for various medical device types and post-market needs.

This post-market clinical follow-up plan template is ideal for regulatory affairs teams, quality managers, and compliance officers, ensuring an effective, compliant approach to clinical surveillance.

Download the ISO 13485:2016 Post-Market Clinical Follow-Up Plan Template today and optimize your post-market safety monitoring!