• MDRs reporting elements for
  • Manufacturers
  • Importers
  • User facilities
• New eMDR program requirements
  • eSubmitter program
  • HL7 electronic submissions
  • Electronic Submissions Gateway (ESG) account
  • Operational deadlines
  • eMDR rejections 
• Revisions to related postmarket programs
  • Quality Assurance coverage
  • Training
  • Corrective and Preventive Actions
• Enforcement

Who Will Benefit:

• Device manufacturers
• Device importers
• User facilities
• FDA consultants
• Domestic and international regulatory affairs managers
• Q.A. managers / training
• Complaint and MDR managers
• Data processing managers
• 3rd party complaint managers