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  • Medical Device Reporting for Manufacturers, Importers and
    Medical Device User Facilities

  • Hosted By:
  • ComplianceOnline
  • Start:
  • Tuesday - Jun 04, 2013 10:00 AM
  • End Time:
  • Tuesday - Jun 04, 2013 11:30 AM
  • Location:
  • Online
  • This webinar on Medical Device Reporting (MDR) will cover FDA requirements for importers, manufacturers and hospitals to report medical device adverse events. It will discuss current policies and guidances for Medical Device Reporting and provide update on upcoming regulations.

    Why Should you Attend:

    The MDR regulation (21 CFR 803) contains mandatory requirements for manufacturers, importers and user facilities to report medical device adverse events.

    This 90-minute webinar will explain the current policies and guidances (1984-current, FDAMA and amendments), provide update on upcoming regulations and discuss what industry, hospitals and patients should know and how to conform to MDR rules. This course will explain the requirements for all these roles in the industry who need to conform with the regulations and the standard process. In addition, the course will describe the voluntary reporting mechanism and tools (MedWatch) for hospitals and consumers. Finally, we will explain further the FDA Event codes for MDRs and the Manufacturer and User Facility Device Experience Database.

    Areas Covered in the Webinar:

    - Overview And Timeline Of Medical Device Reporting(MDR) at US FDA
    - Requirements for Individual Adverse Event Reports
    - User Facility Reporting Requirements
    - Importer Reporting Requirements
    - Manufacturer Reporting Requirements
    - MedWatch voluntary reporting & MedWatcher mobile app
    - Event Codes for MDRs
    - Manufacturer and User Facility Device Experience Database(MAUDE)
    - Strengthening medical device postmarket surveillance , UDI (2012 report-FDA)
  • Website:
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