SOP Post-Market Surveillance
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Use this SOP Post-Market Surveillance template to establish, document, and maintain your medical device post-market surveillance processes, ensuring systematic collection and analysis of safety, performance, and quality data for devices placed on the EU market. You should complete this template when your devices are commercially available, to define and manage PMS plans, reports (PMSR, PSUR), and trend analysis activities required for ongoing regulatory compliance, risk management, and improvement actions. This SOP is crucial for meeting EU MDR/IVDR requirements and demonstrating proactive vigilance throughout your product’s lifecycle.