FDA-Compliant Medical Device Reporting (MDR)
Overview:
This webinar is intended to demonstrate how to define, document, implement, and maintain the necessary procedures for medical device reporting.
In the United States, since December 13, 1984, the Food and Drug Administration (FDA) Medical Device Reporting (MDR) regulations have required firms who have received complaints of device malfunctions, serious injuries or deaths associated with medical devices to notify FDA of the incident.
MDR is the mechanism for the FDA to receive significant medical device adverse events from manufacturers, importers and user facilities, so they can be detected and corrected quickly. It is critical to understand how to define, document, implement, and maintain the procedures for MDR.
This webinar will greatly help device industry and relevant professionals understand how to define, document, implement, and maintain the procedures for MDR.
Why Should You Attend: IDevice manufacturers are required to establish and maintain a medical device adverse event reporting system, commonly known as Medical Device Reporting. This webinar will demonstrate how to define, document, implement, and maintain the necessary procedures for medical device reporting.
Areas Covered in the Session:
- Relevant Statutes and FDA Regulations
- Definitions
- Regulatory Requirements for Medical Device Reporting (MDR)
- Requirements to Be Addressed in the Procedures
- How to Fill Out MDR Forms
- How and Where to Report Medical Device Adverse Events
- Reporting Requirements for the User Facilities, Manufacturers, and Importers
- Enforcements: Numerous Case Studies
Who Will Benefit:
- Complaint Handling, Risk Management Managers and Directors
- Compliance Officers and Legal Counsel
- Regulatory Affairs
- Clinical Affairs
- Quality Assurance, Quality Control, and Quality Systems
- Research and Development
- Product and Development
- Marketing
- Site Managers and Consultants.
- Contract Manufacturing Organization
- Contract Research Organization
- Senior and Executive Management
- Contractors and Subcontractors.