Points of Consideration during Medical Device Design and Development - Dos and Donts

Duration: 60 Minutes
This webinar is intended to discuss important aspects of medical device design and development. Under the Federal Food, Drug, and Cosmetic Act (FD & C Act or the Act), a medical device firm is subject to design control requirements, to the extent applicable during development including clinical trials and post-marketing. Based on the FDA enforcement trends, design control failure are frequently cited in 483s and FDA warning letters.
Medical Device Design
Instructor: David Lim
Product ID: 500531

FDA warning letters state "Failure to establish and maintain adequate procedures to control the design of the device in order to ensure specified design requirements are met." In addition, due to device design control failures, it has resulted in many device recalls.

This webinar is intended to provide guidance on what key considerations should be focused during medical device development under the surrounding circumstances. It is also intended to provide further guidance on how to establish and maintain design control procedures in a way to survive an FDA inspection applicable for all classes of medical devices including IVDs.

In particular, this webinar will discuss various device design failures as examples to greatly increase our awareness. It should be noted that an adequate understanding, interpretation, and implementation of design control system requirements in a holistic manner can significantly contribute to your product quality and regulatory compliance, helping to ensure your innovative medical products safe and effective on the global market. As a result, your adequate implementation of design control will significantly contribute to saving an enormous amount of your unnecessary time, efforts and investment for a long term.

This webinar is a must for medical device and IVD firms conceptualizing, developing and marketing medical devices including anyone interested in the topics from other industry. It will also provide great opportunities to streamline device design and development process including regulatory approval/clearances and post-marketing.

Why Should you Attend:
  • You need to ask sets of questions during medical device concept phase for developing intended use/user needs.
  • It is important to ensure you are familiar with the regulatory requirements applicable for medical device design and development.
  • Based on the regulatory requirements, firms shall establish and maintain adequate medical device design control procedures.
Objectives of the Presentation:
  • Statutes and Regulations
  • Device Design Concept
  • Definitions
  • Design and Development Planning
  • Key Considerations
  • Design Control System Components
  • Design Control Sub-Systems
  • Design Input and Design Output
  • Design Review
  • Design V and/or V
  • Design Transfer and Design Changes
  • Design History File (DHF), Device History Record (DHR) and Device Master Record (DMR)
  • Common Mistakes and How to Avoid
  • How to Prepare for FDA inspection for Design Control
  • Best Practices based on Actual Cases
  • Speaker's Recommendation and Suggestions on PASS-IT Solutions
Who can Benefit:
  • 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
  • Contractors/subcontractors
  • CEOs
  • VPs
  • Clinical affairs (associates, specialists, managers, directors or VPs)
  • Other interested parties
Live Session - How it works
  • Username and Password will be sent to you 24 hours prior to the webinar
  • Presentation handouts in pdf formate will be mailed to you
  • Login to the session using the username and password provided to you
  • Get answer to your queries through interactive Q&A sessions via chat
  • Please let us know your thoughts and views at the end of webinar, your valuable feedback will help us improve
  • Get certification of attendance.
Recorded Session - How it works
  • A link will be provided to you upon purchase of the recorded session
  • Please click on the link to access the session
  • Presentation handouts in pdf formate will be mailed to you
  • Get certification of attendance.
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Recorded Session for one participant
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Live Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • The webinar joining link, username and password for joining the webinar will be updated on your OCP Account 24 hours prior to the webinar
  • Presentation handouts in Downloadable PDF format will be updated on your OCP Account 24 hours prior to the live session
  • Login to the audio conference on the scheduled date and time
  • Get answers to your queries through interactive Q&A sessions via chat at the end of the session
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account 24 hours after the completion of the session
  • Please let us know your thoughts and views at the end of the webinar, your valuable feedback will help us improve
Recorded Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • Upon purchase of the recorded session a link will be updated on your OCP Account within 24 hours
  • Please click on the link to access the Recorded Session
  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account after 48 hours of the product Purchase
  • Please share your valuable Feedback at the end of the session
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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