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Best Practices and FDA Compliant Medical Device Reports MDRs Recall Corrections and Removals Description: 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 Definitions 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 Enforcements: case studie. Who can Benefit: CEOs VPs 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 Consultants Contractors/Subcontractors Other Interested Parties


Training Options Duration: 60 Minutes Recorded Session Access recorded sessions only for one participant unlimited viewing for 6 months. Price: $288.00


Best Practices and FDA Compliant Medical Device Reports MDRs Recall Corrections and Removals