Periodic Safety Update Report (PSUR) Procedure

The Periodic Safety Update Report (PSUR) Procedure provides detailed guidance on the required content of a Periodic Safety Update Report (PSUR) made part of the company’s post market surveillance and vigilance system.

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Periodic Safety Update Report (PSUR) Procedure

The Periodic Safety Update Report (PSUR) Procedure provides detailed guidance on the required structure and content of Periodic Safety Update Report (PSUR) for Class IIa, Class IIb, and Class III medical devices.

Periodic Safety Update Report (PSUR) Procedure - Overview

The PSUR procedure notes all required sections of a Periodic Safety Update Report and provides detailed instruction to guide the user to properly address each PSUR section. The PSUR procedure covers every report element such as; risk-benefit determination, signal and risk evaluation, clinical trial summaries and findings, summary tabulations and more.