Post Market Surveillance Plan Template - ISO 13485

Effectively monitor, analyze, and improve medical device performance with our ISO 13485:2016 Clause 4.2 (Medical Device File) Post-Market Surveillance (PMS) Plan Template. A Post-Market Surveillance Plan is essential for ensuring continuous product safety, risk management, and regulatory compliance, aligning with ISO 13485:2016, MDR, IVDR, FDA 21 CFR Part 820, and ISO 14971. This structured template provides a systematic approach for collecting, evaluating, and responding to post-market data.

✔ Pre-Formatted PMS Plan Template – Covers key ISO 13485:2016 Clause 4.2 requirements.

✔ Data Collection & Monitoring Strategy – Define methods for gathering real-world product performance data.

✔ Complaint Handling & Vigilance Reporting – Align with regulatory post-market obligations (MDR, IVDR, FDA).

✔ Risk Management & CAPA Integration – Ensure ISO 14971 risk mitigation measures are implemented.

✔ Trend Analysis & Continuous Improvement Section – Monitor recurring issues and quality improvements.

✔ Responsibilities & Reporting Workflow – Assign accountability for post-market surveillance activities.

✔ Audit-Ready Documentation – Maintain comprehensive PMS records for regulatory inspections.

✔ Editable Digital Format – Fully customizable for various medical devices and market needs.

This ready-to-use PMS Plan template is ideal for quality managers, regulatory professionals, and medical device manufacturers, ensuring a structured, compliant, and proactive approach to post-market surveillance.

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