Best Practices for Implementing an Adverse Event Reporting System for Medical Devices Including IVDs 2014 is a webinar that covers topics such as:
- Definitions
- Applicable statutes and regulations
- How to report an adverse event
- Regulatory requirements for Medical Device Reporting
- Required elements to be contained in your standard operating procedures
- Reporting requirements for the user facilities, manufacturers, and importers
- Enforcements: Case Studies
- How to implement an adverse event reporting system
- Good Practices
Best Practices for Implementing an Adverse Event Reporting System for Medical Devices Including IVDs 2014 is intended for:
- VPs
- CEOs
- Quality professionals (associates, specialists, managers, directors or VPs)
- Regulatory affairs (associates, specialists, managers, directors or VPs)
- Complaint and risk management personnel
- R&D (engineers, scientists, managers, directors or VPs)
- Contractors/subcontractors
- Consultants
- Other interested parties
- Clinical affairs (associates, specialists, managers, directors or VPs)
