Course Description:

Course "An Interactive Workshop on Design Control for Medical Devices Including In Vitro Diagnostic Devices" has been pre-approved by RAPS as eligible for up to 6 credits towards a participant's RAC recertification upon full completion.

At this workshop, Dr. David Lim will walk you through to get familiar with the following subject area.

Establishing Design Control for Medical Devices Including In Vitro Diagnostic Medical Devices (IVDs).

This workshop is intended to provide guidance on interpreting, understanding, establishing and maintaining design control for all classes of medical devices including IVDs.

During this workshop (October 31), defining, documenting and implementing design control procedures for medical devices including in vitro diagnostic devices will be discussed.

Why Should You Attend:

Understanding design control 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.

At this workshop, you will get familiar with regulatory and quality requirements of design control concerning medical devices, active implantable medical devices and in vitro diagnostic medical devices.

The following key areas will be discussed during workshop:

  • Federal Statutes and Regulations Governing Medical Devices in the US
  • Design Controls
    • Introduction
    • Design And Development Planning
    • Design Input
    • Design Output
    • Design Review
    • Design Verification And Validation
    • Design Evaluation Versus Specifications
    • Software Validation
    • Labeling Verification
    • Design Transfer
    • Design Changes
    • Design History File

Who will Benefit:

This seminar will be valuable for anyone in the FDA-regulated industry, including, but not limited to, all classes of medical devices, active implantable medical devices, in vitro diagnostic medical devices or combination products. This seminar will be particularly useful for those who are involved in research and development, quality, clinical and regulatory affairs and compliance.

This workshop is a must for those directly or indirectly involved in research and development, quality, clinical and regulatory affairs handling documentation for 510(k)s and PMAs. In addition, this workshop will also be very beneficial to those preparing for and handling conformity assessment applications for CE marking purposes.

The following employees who will benefit include:

  • Regulatory affairs (associates, specialists, managers, and directors)
  • 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)
  • Contract research organization (associates, scientists, managers, directors and VPs)
  • Site managers, and consultants
  • Senior and executive management (VPs, SVPs, Presidents and CEOs)
  • Contractors and subcontractors
  • Anyone interested!

Course Outline:

Schedule for Day 1, 9:00 AM - 4:00 PM | (Quality System Regulations and Design Control)
9:00 AM - 10:30 AM
[Quality System Regulations; QSRs: cGMP]
  • Federal statutes and regulations
  • Introduction
  • Design And Development Planning
  • Design Input
10:30 AM - 10:40 AM Short Break
10:40 AM - 12:00 Noon
[Quality System Regulations; QSRs: cGMP]
  • Design Output
  • Design Review
12:00 Noon - 1:00 PM Lunch
1:00 PM - 2:30 PM
[Design Control]
  • Design Verification And Validation
  • Design Evaluation Versus Specifications
  • Software Validation
2:30 PM - 2:40 PM Short Break
2:40 PM - 4:00 PM
[Design Control]
  • Labeling Verification
  • Design transfer
  • Design changes
  • Design history file (DHF)
  • Device History Record (DHR)
  • Device master record (DMR)

Meet Your Instructor

Dr. David Lim

Dr. David 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 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, 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, regulatory compliance, quality and clinical affairs. Currently, Dr. Lim is serving as a faculty at the Regulatory Affairs Professional Society (RAPS) and is an advisor to the Presidents and CEOs of FDA-regulated industry.

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Written cancellations through fax or email (from the person who has registered for this conference) received at least 10 calendar days prior to the start date of the event will receive a refund — less a $100 administration fee. No cancellations will be accepted — nor refunds issued — within 10 calendar days from the start date of the event.

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We discourage onsite registrations, however if you wish to register onsite payment to happen through credit card immediately or check to be submitted onsite. Conference material will be given on the spot if it is available after distributing to other attendees. In case it is not available we will send the material after the conference is over.

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I think the material and instructor were very knowledgeable and material was excellent. The subject was well chosen and the design of presentation was most appropriate.
- QC, Regulatory affair

My colleague referred me to this event and It was good value for the price. Excellent friendly presenter and coordinator. The amount of interaction between the participants and presenters was ideal. I would also like to recommend this seminar to others.
- Regulatory Manager

I think the instructor were very knowledgeable and material was excellent. Example and templates of PMA & 510k submissions were very useful because it set the framework of how to submit a quality 510k.
- Regulatory Manager

I had very focused reason to attend this seminar: learning more about 510k, classes and requirements. The program was well organized and coordinated by ComplianceOnline.
- Quality Analyst

Dr. Lim is very knowledgeable. The amount of interaction between the participant and presenter was ideal. I would like to refer his trainings to my colleagues.
- QC, Regulatory Affairs

All the topics were well chosen and the design of the presentation was most appropriate. I like the topic “Template for Submission” most. David Lim is an excellent friendly presenter. Overall it was good value for the price with ComplianceOnline.
- Managing Director

ComplianceOnline Seminar offered a lot of valuable and relevant information. Thanks for organizing it very well and professionally. I would like to attend next seminar with in depth classification of medical device.
- Manufacturing Engineer

Speaker was great. The event was well organized and coordinated by ComplianceOnline. I would recommend this to others. Thanks!
- Attorney (Patent)

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