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. Device firms are also subject to compliance to the FDA regulations of device recalls, correction and removals. To achieve compliance and to remain compliant, it is critical to understand how to define, document and implement the procedures for MDR, recalls, corrections and removals.
This webinar is aimed at helping device industry understand how to establish procedures for MDR, recalls, corrections and removals and further provide practical and actionable perspectives by increasing awareness and familiarity of the regulatory requirements.
At the end of the webinar, you will get empowered in a way that you would plan, develop and execute the relevant procedures efficiently and effectively.
Objectives of the Presentation:
Relevant statutes and FDA regulations
Regulatory requirements for MDRs, recalls, corrections and removals
How to report medical device adverse events
Reporting requirements for the user facilities, manufacturers, and importers
Recalls, corrections and removals (devices)
Voluntary recalls and mandatory device recalls
How to perform and document corrections and removals
Who can Benefit:
Clinical Affairs (Associates, Specialists, Managers, Directors or VPs)
Regulatory Affairs (Associates, Specialists, Managers, Directors or VPs)
Quality Professionals (Associates, Specialists, Managers, Directors or VPs)
R&D (Engineers, Scientists, Managers, Directors or VPs)
Complaint and Risk Management Personnel
Other Interested Parties
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