Product Overview
Post Market Surveillance
We provide comprehensive Post-Market Surveillance (PMS) services to help medical device manufacturers ensure continuous compliance, safety, and performance throughout the product lifecycle. Our PMS activities are aligned with EU MDR 2017/745, IVDR 2017/746, and other applicable global regulations, enabling proactive risk management, early signal detection, and effective regulatory communication. We support manufacturers in meeting post-market obligations while strengthening patient safety and sustaining long-term market access.
Saraca’s Post-Market Surveillance Services include:
– Development, implementation, and maintenance of PMS Plans in accordance with EU MDR / IVDR requirements
– Complaint handling and trending, including identification of recurring issues and emerging risks
– Adverse event reporting and vigilance submissions to competent authorities within required timelines
– Corrective and Preventive Action (CAPA) management supported by structured root cause analysis
– Vigilance database searches (e.g., recalls, safety notices) and ongoing signal detection
– Support for Field Safety Corrective Actions (FSCA) and preparation of Field Safety Notices (FSN)
– Preparation of PMS Reports (PMSR) and Periodic Safety Update Reports (PSUR) based on device risk class
– Post-Market Clinical Follow-up (PMCF) and Post-Market Performance Follow-up (PMPF) planning and reporting
– Regulatory coordination and communication with notified bodies and competent authorities
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