Post Market Surveillance for Medical Devices 2012

Topics

• US System
  
  • Medical Device Reports
  • Complaints (QSR)
  • Corrections and Removals
• The Structure of Post Market Surveillance
• Post Production Information Collection
  
  • Clinical Evaluation (MDD Annex X)
  • Risk Management (ISO 14971)
• International Systems
  
  • EU Vigilance
  • Complaints (ISO 13485)
  • Canada Adverse Event Reporting
  • EU FSCA and FSN

Who should Attend

Regulatory Affairs Managers, Quality Managers, Design Control Managers and Risk Managers.