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PSUR Report Template and Guidelines by Mauro Costa is a document available to read on EtoBox.

What is PSUR Report Template and Guidelines about?

This document provides a template for a Post-Market Surveillance Report (PSUR) that includes: 1. An executive summary that declares whether the benefit-risk ratio has been negatively impacted. 2. A description of the devices covered, their intended uses, contraindications, and warnings. 3. Presentation and evaluation of post-market data including clinical studies, vigilance data, preventative and corrective actions, and other post-market surveillance sources. The data is to be analyzed for safety signa

Author

Mauro Costa

Language

EN