FDA-Compliant Medical Device Reporting (MDR) 2013

Topics

• Definitions
• Relevant Statutes and FDA Regulations
• Requirements to Be Addressed in the Procedures
• Regulatory Requirements for Medical Device Reporting (MDR)
• How and Where to Report Medical Device Adverse Events
• How to Fill Out MDR Forms
• Enforcements: Numerous Case Studies
• Reporting Requirements for the User Facilities, Manufacturers, and Importers

Who should Attend

• Compliance Officers and Legal Counsel
• Complaint Handling, Risk Management Managers and Directors
• Clinical Affairs
• Regulatory Affairs
• Research and Development
• Quality Assurance, Quality Control, and Quality Systems
• Marketing
• Product and Development
• Contract Manufacturing Organization
• Site Managers and Consultants
• Senior and Executive Management
• Contract Research Organization
• Contractors and Subcontractors