Device Corrections and Removals is a webinar that covers topics such as:
- 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- The draft guidance
Device Corrections and Removals 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.
