Device Corrections and Removals 2012 is a webinar that covers topics such as:
- 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- Design changes and potential 510(k) submissions: The draft guidance and The current guidance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
Device Corrections and Removals 2012 brings together 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.
