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