Device Corrections and Removals 2014

Key Topics

• When to report
• The basic requirements of Part 806
• Market withdrawal
• Exemptions that you may apply
• Stock recovery
• Routine servicing
• Reporting under Part 1004 – Repurchase, Repairs, or Replacement of Electronic Products
• Reporting under Part 803 – Medical Device Reports
• The requirements for records when you don’t report
• The requirements of a report and the timing
• Elements of a robust system
• The expectations of a QSIT Inspection
• Recalls
• How to check your system for compliance
• The current guidance
• Design changes and potential 510(k) submissions
• The draft guidance

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.