Establishing a Medical Device Reporting System Integrated with a UDI System

Duration: 60 Minutes
This webinar is intended to help you get familiar with the Medical Device Reporting (MDR) pursuant to the Federal Food, Drug, and Cosmetic Act (FD&C Act or the Act).
Medical Device Engineering
Instructor: David Lim
Product ID: 500233

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, deaths or serious injuries 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 accurately interpret and understand MDR regulations, and in particular, how to precisely define, document and implement MDR procedures to achieve compliance and to remain compliant with the MDR regulations in a sustainable manner.

This webinar is aimed at helping device industry accurately interpret how to establish MDR procedures and further provide practical, actionable and sustainable perspectives with improved awareness and familiarity of the applicable regulatory requirements including a UDI system integration.

This webinar will further help you establish and maintain an MDR system in a less burdensome, integrated, and thorough manner.

Why Should you Attend:
This webinar will provide great opportunities to get familiar with the FDA compliant medical device reporting requirements.

Objectives of the Presentation:
  • Overview of Relevant Laws and Regulations
  • Definitions
  • Regulatory Requirements for MDR Procedures
  • How to Report A Medical Device Problem (MDR)
  • Reporting Requirements for the User Facilities, Manufacturers, and Importers
  • Relationships with Adverse Event Reporting Systems in EU and Health Canada
  • UDI System Integration
  • Enforcements: Case Studies
  • Conclusion
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
  • Anyone interested in the topics
$375
Recorded Session for one participant
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Instructor Profile:
Dr. David Lim is President and Principal of Regulatory Doctor. Regulatory Doctor provides Practical, Actionable, and Sustainable Solutions in an Integrated, Thorough ("PASS-IT") manner.

Dr. Lim 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, Dr. Lim has held various positions at Duke, Caltech, US National Laboratories, Intrexon Corporation, Terumo, US FDA/CDRH, and EraGen Biosciences, Inc., 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 (www.RegulatoryDoctor.com), Dr. Lim was Senior Vice President of Scientific and Regulatory Affairs at Aquavit Pharmaceuticals, Inc. in New York. Dr. Lim as Regulatory Doctor provides practical, actionable and strategic solutions integrated with emotional intelligence (EQ) skills for all aspects of global regulatory, quality, clinical and compliance matters.

Over the years, Dr. Lim has analyzed thousands of FDA warning letters including thousands of MDRs. Dr. Lim has also attended more than 50 FDA advisory panel Meetings and analyzed the subject matters and decision-making processes. Dr. Lim is familiar with hundreds of medical products (medical devices including IVD products, biologics, drugs and combination products). Dr. Lim is a certified professional for regulatory affairs (RAC) and also is a certified quality auditor (CQA) by the American Society for Quality (ASQ). Dr. Lim also is a regulatory coach, mentor, consultant and public speaker for global matters pertaining to regulatory affairs, regulatory compliance, quality and clinical affairs. Dr. Lim has been actively engaged in identifying and addressing regulatory hurdles and submission issues including, but not limited to, patient-safety signals and concerns. Dr. Lim co-authored the Regulatory Affairs Professional Society (RAPS)'s online class materials for EU medical device regulations.
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