Theme Post-market surveillance 
Target Audience Manufacturers
Products concerned MD, IVD 

The purpose of this guide is to:   

  • Introduce the post-marketing surveillance (PMS) system  
  • Describe the content and structure of the PMS plan  
  • Outline the main activities associated with the PMS system  
  • Clarify the interactions between the PMS system and other key elements of the quality management system (QMS) 
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