Post Market Solutions

We deliver strategic PMS solutions for Medical Devices, IVDs, and Pharmaceuticals,  fully aligned with EU MDR, IVDR, and applicable MDCG guidance. From PMS and PMPF planning to PSURs and trend analysis reports and submission. We help manufacturers maintain regulatory compliance, proactively monitor device performance by post market information, and ensure ongoing benefit-risk justification by the below solutions;

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Services;

• EU MDR (2017/745), US FDA, QMSR, UK MHRA, and ISO 13485:2016.

• Post-Market Surveillance Management

• Periodic Safety Update Reports

• EUDAMED

• Incident Management

• Trend Analysis and Reporting System

• Field Safety Corrective Actions

• CAPA