Stay ahead of regulatory requirements and protect patient safety with our comprehensive Post-Market Surveillance (PMS) Plan — a professionally structured document template designed for medical device manufacturers operating in today's demanding compliance landscape.

This PMS Plan provides a complete, audit-ready framework for collecting, recording, and analysing production and post-production data across your entire device portfolio. Built to align with current regulatory expectations, it establishes consistent, repeatable procedures that support ongoing device oversight long after market placement.

The plan covers the full scope of post-market obligations, including continuous benefit-risk determination, risk management updates, and the refinement of clinical evaluations as real-world data accumulates. It also addresses the critical need to keep design and manufacturing information, instructions for use, and labelling current and accurate throughout a device's lifecycle.

Beyond compliance, this PMS Plan is a practical operational tool. It provides structured mechanisms for identifying the need for preventive, corrective, or field safety corrective actions before issues escalate, and supports continuous improvement of device usability, performance, and safety. Built-in trend detection and reporting capabilities ensure that emerging signals are identified and acted upon promptly.

Fully customisable to your specific device range, the plan is designed for initial annual review cycles, with the flexibility to adjust review frequency based on surveillance outcomes and any changes to the device or its intended use. Whether you're preparing for a notified body audit, a regulatory submission, or simply building a stronger post-market quality system, this template gives your team a clear, compliant starting point.