Device Corrections and Removals 2012

Key Topics

• When to report
• The basic requirements of Part 806
• The requirements of a report and the timing
• Exemptions that you may apply
  
  • Routine servicing
  • Market withdrawal
  • Reporting under Part 803 – Medical Device Reports
  • Stock recovery
  • Reporting under Part 1004 – Repurchase, Repairs, or Replacement of Electronic Products
• The expectations of a QSIT Inspection
• The requirements for records when you don`t report
• How to check your system for compliance
• Elements of a robust system
• Design changes and potential 510(k) submissions: The draft guidance and The current guidance
• Recalls

Who should Attend

Attendees involved in risk management, complaints, regulatory affairs and customer communication, including Regulatory Professionals, Quality Professionals, Complaint Managers and Specialists, Risk Management Specialists, General/Corporate Counsel, Compliance Officers and Regulatory/Legislative Affairs Professionals.