Global medical device regulations require manufacturers to actively collect, analyze, and act upon post-market data throughout the product lifecycle. This includes complaint handling, vigilance reporting, trend analysis, and periodic safety evaluations. Authorities increasingly expect structured PMS plans supported by real-world data and clear escalation pathways.
An effective PMS and vigilance system integrates seamlessly with the quality management system, enabling timely identification of safety signals and implementation of corrective actions. Clear procedures, trained personnel, and regular reviews ensure regulatory compliance while strengthening trust with regulators and end users. A proactive approach to post-market surveillance not only reduces compliance risk but also supports continuous improvement and long-term device performance.
