Medical Device Expert Consultant: Dr. David Lim
David Lim (Dr. Lim) is President and Principal of Regulatory Doctor. He is a leading FDA consultant, expert, regulatory and compliance speaker. Regulatory Doctor provides practical, actionable, and sustainable solutions/strategies in an integrated, thorough (“PASS-IT”) manner. He recently authored an article entitled “Demystifying the FDA Appeals Process.” 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 University Medical Center (Duke), California Institute of Technology (Caltech), US National Laboratories, UC-Berkeley, 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 (Regulatory Doctor), Dr. Lim was Senior Vice President of Scientific and Regulatory Affairs at Aquavit Pharmaceuticals, Inc. in New York, wherein Dr. Lim provided inspiring and actionable solutions for sustainable business operation. Dr. Lim as Regulatory Doctor provides Practical, Actionable and Sustainable Solutions in an Integrated, Thorough (“PASS-IT”) manner equipped with emotional intelligence (EQ) skills for all aspects of global regulatory, quality, clinical and compliance matters.
Over the years, Dr. Lim has analyzed over thousands of FDA-issued warning letters including over thousands of MDRs. Dr. Lim has also attended more than 50 FDA Advisory Committee Panel Meetings and analyzed the subject matters and decision-making processes in detail. 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 instructor for global matters pertaining to regulatory affairs, regulatory compliance, quality and clinical affairs. Currently, Dr. Lim works with a number of professionals to better and proactively identify and address patient-safety signals and issues.
To learn about Dr. Lim’s 510(k) LIVE online seminar (510(k) webinar), click here or below.
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