Topics
- Regulatory Requirements for MDR, Recall, Correction and Removal
- Review of Relevant Statutes and FDA regulations
- How to Report A Medical Device Problem (MDR)
- Definitions
- Recalls, Corrections and Removals (Devices)
- Reporting Requirements for the User Facilities, Manufacturers, and Importers
- Corrections and Removals
- Voluntary Recalls and Mandatory Device Recalls
- Enforcements: Case Studies
Who should Attend
VPs, CEOs, Regulatory affairs (associates, specialists, managers, directors or VPs), Clinical affairs (associates, specialists, managers, directors or VPs), R&D (engineers, scientists, managers, directors or VPs), Quality professionals (associates, specialists, managers, directors or VPs), Consultants, Complaint and risk management personnel.
