David Lim
Instructor David Lim
Product Id 600938
Duration 60 Minutes  
Version Recorded
Original Price $295
Special Offer Price $10
Refund Policy
Access recorded version only for one participant; unlimited viewing for 6 months

Medical Device Design Control


Understanding, interpreting, and implementing design control requirements in a holistic manner can significantly expedite the regulatory processes, bringing innovative medical products to the global market faster and saving enormous amount of your unnecessary time, efforts and investment.

In this presentation, you will get familiar with regulatory and quality requirements of design control concerning medical devices, active implantable medical devices and IVDs.

This webinar will greatly help medical device industry and relevant professionals establish and maintain adequate design control procedures.

Why Should You Attend: Device manufacturers are required to establish and maintain the FDA-compliant quality management systems, where appropriate and applicable, including design control. This webinar is intended to provide guidance on understanding, interpreting, and implementing design control requirements. This presentation is further intended to help you establish and maintain adequate design control procedures for all classes of medical devices including IVDs.

Areas Covered in the Session:

  • Federal Statutes and Regulations Governing Medical Devices in the US
  • Introduction and Definitions
  • Design and Development Planning
  • Design Input
  • Design Output
  • Design Review
  • Design Verification And Validation including Software Validation
  • Design Transfer
  • Design Changes
  • Design History File (DHF)
  • Device History Record (DHR) and Device Master Record (DMR)

Who Will Benefit:
  • R&D Scientists, Engineers, Managers, and Directors
  • Regulatory Affairs
  • Quality Professionals
  • Product Development Professionals
  • CROs
  • Consultants
  • Senior Management
  • Contractors and Subcontractors
  • Anyone interested in design control

Speaker Profile
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, US National Laboratories, Intrexon Corporation, Terumo, US FDA/CDRH, and EraGen Biosciences, Inc., A Luminex Company. In 2009, Dr. Lim served as a 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, wherein Dr. Lim provided inspiring and actionable solutions for sustainable business operation. 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 over 1,000 FDA warning letters. Dr. Lim has also attended more than 50 FDA Advisory Panel Meetings and analyzed the subject matters and decision-making processes in detail. Dr. Lim is familiar with more than 200 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 is an auditor, regulatory coach, consultant and instructor for global matters pertaining to regulatory affairs and compliance, quality and clinical affairs.

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