Best Practices for Medical Device Reporting (MDR), Recall, Reports of Corrections and Removals

Why Should You Attend:

The FDA's 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. Device firms are also subject to compliance to the FDA regulations of device recalls, reports of corrections 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 develop, maintain and implement the 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, maintain and implement the relevant procedures efficiently and effectively.

Areas Covered in the Webinar:

• Relevant Statutes And FDA Regulations.
• Definitions.
• Regulatory Requirements For Medical Device Reporting (MDR).
• How To Report A Medical Device Problem (MDR).
• Reporting Requirements For The User Facilities, Manufacturers, And Importers.
• Regulatory Requirements for Recall, Reports of Corrections And Removals.
• Requirements To Be Addressed In the Procedures.
• Enforcements: Case Studies.

Who Will Benefit:

This webinar will be valuable for anyone in global medical device industry including, but not limited to, those working on drugs, biologics and in vitro diagnostic devices who are involved in the processes of adverse event reporting, recall, reports of corrections and removals, complaint handling and regulatory compliance.

The employees who will benefit include:

• Complaint handling personnel.
• Regulatory affairs (associates, specialists, managers, and directors).
• Clinical affairs (associates, specialists, coordinators, managers, directors and VPs).
• Quality assurance, quality control, and quality systems (associates, specialists, engineers, managers, directors and VPs).
• Research and development (associates, scientists, managers, directors and VPs).
• Product and development (associates, scientists, managers, directors and VPs).
• Marketing (associates, specialists, managers, directors and VPs).
• Site managers, and consultants.
• Contract manufacturing organization (associates, scientists, managers, directors and VPs).
• Contract research organization (associates, scientists, managers, directors and VPs).
• Senior and executive management (VPs, SVPs, Presidents and CEOs).
• Contractors and subcontractors.

Instructor Profile:

Dr. David Lim, president and principal of Regulatory Doctor, obtained his Ph.D. in biological sciences at the University of Missouri-Columbia and published his thesis research in the prestigious journal “Science.” Since then, he has held various positions at Duke, Caltech, US National Laboratories, Intrexon Corporation, Terumo, US FDA/CDRH, and EraGen Biosciences (A Luminex Company). In 2009, Dr. Lim served as a panel member during the FDA’s Transparency Public Meeting. Prior to founding his own consulting firm, Dr. Lim was senior vice president of scientific and regulatory affairs at Aquavit Pharmaceuticals. Regulatory Doctor provides practical, actionable and sustainable/strategic solutions in an integrated, thorough (PASS-IT) manner for all aspects of global regulatory, quality, clinical and compliance matters.

Dr. Lim has analyzed over 1,000 FDA warning letters, attended more than 50 FDA advisory panel meetings, and analyzed the subject matters and decision-making processes in detail. He is familiar with more than 200 medical devices, IVD products, biologics, drugs and combination products. Dr. Lim is a certified professional for regulatory affairs (RAC) and is also a certified quality auditor (CQA) by the American Society for Quality (ASQ). In addition, he has completed two years in law school. He is an auditor, regulatory coach, mentor, consultant and instructor for global matters pertaining to regulatory affairs, quality, clinical affairs and compliance.

Topic Background:

To achieve sustainability and to remain sustainable and competitive in medical device markets, it is necessary to streamline the regulatory compliance processes.

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.

By understanding the adverse event reporting requirements, recall, and reports of corrections and removals in a systematic, integrative manner, the process owners can better define, document, implement and maintain the compliant procedures, improving patient safety and achieving regulatory compliance.

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