Post-Market Surveillance Plan
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Use this Post-Market Surveillance (PMS) Plan template to systematically outline how you will collect, analyze, and report safety and performance data for your medical device after it has been placed on the market. This document is essential for meeting EU MDR and FDA requirements, guiding you on vigilance data sources, complaint handling, trend analysis, and corrective actions, and should be filled out before product launch and regularly updated during the device’s lifecycle. Completing this plan ensures you proactively identify and address risks, maintain regulatory compliance, and provide the necessary input for your PMS or PSUR reports.