Best Practices for Medical Device Reporting (MDR), Recall, Reports of Corrections and Removals 2012

Key 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.