Implementing a Medical Device Reporting (MDR) System Integrated with a UDI System 2014 is a webinar that covers topics such as:
- Definitions
- Statutes and Regulations
- New MDR Requirements
- Regulatory Requirements for MDR Procedures
- Reporting Foreign Events
- MDR Event Criteria
- Reporting Requirements for the User Facilities, Manufacturers, and Importers
- How to Report A Medical Device Problem (MDR)
- UDI System Integration
- Relationships with Adverse Event Reporting Systems in EU and Health Canada
- Good Practices: Suggestions and Recommendations
- Common Mistakes
- Conclusion
Implementing a Medical Device Reporting (MDR) System Integrated with a UDI System 2014 is intended for:
- 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
