How to Prepare a Post-Market Surveillance Report (PMSR) for Medical Devices


Pmconsultant1114

Uploaded on Feb 2, 2026

Category Business

In today’s highly regulated medical device landscape, post market surveillance consulting plays a critical role in ensuring devices remain safe, effective, and compliant throughout their lifecycle. Manufacturers are increasingly expected to monitor real-world performance, track adverse events, and systematically document findings to meet both FDA and EU MDR requirements. A well-prepared Post-Market Surveillance Report (PMSR) not only supports regulatory compliance but also strengthens patient safety and enhances the overall quality management system of a medical device organization.

Category Business

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