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- Design changes and potential 510(k) submissions: The draft guidance and The current guidance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.
