Periodic Safety Update Report (PSUR) Writing

Agenda

Module 1 Introduction to the PSUR including legal MDR  basis

Module 2 General Principles and Structure of the PSUR 

Module 3 Planning the Process  

Module 4 Writing of the PSUR Section-by-Section

     Introductory Sections 

     Presentation of Findings 

     Data Evaluation 

     Benefit-Risk Analysis 

Learning Objectives                                                                                                      
 The main objective of the PSUR is to present a comprehensive, concise, and critical analysis of the benefit-risk balance of the medical device  product, taking into account new or emerging information in the context of cumulative information on benefit-risk in the post-marketing environment