MDRs - Bureaucracy or Benefit 2015

Topics

• Consequences for Non-Reporting and Over-Reporting
• Medical Device Reporting History, Overview, and Basics
• When do malfunctions need to be reported?
• Definitions: Serious Injury, Death, Malfunction, User Error, Reportable Event
• MDR for Manufacturers and Importers
• The eMDR System
• The MAUDE Database

Who should Attend

• Medical Device Importers
• Medical Device Manufacturers
• Pharmacies
• Hospitals and Long Term Care Facilities