FDA Regulation on 3D Printing and Medical Devices

Duration: 90 Minutes
This 90-minute webinar on 3D printing will cover FDA's expectations regarding the design, manufacture, testing and approval of 3D printed medical devices. As technological advancements continue to permeate the medical device world, few hold more promise than 3-D printing. Everything from prosthetics to organs have been (or can be, theoretically) “printed.” Thus, the opportunity presented has intrigued device firms because of increased product efficacy, manufacturing benefits, and other advantages. Now that the guidance 'Technical Considerations for Additive Manufactured Devices' (May, 2016) has been finalized, many questions have been answered but several remain. What does this guidance mean? How do I enter the market? What are the considerations regarding scale-up for manufacturing of product?
3D Printed Medical Devices
Instructor: Rachelle D'Souza
Product ID: 501867
Objectives of the Presentation
  • An Introduction to 3D Printing (includes brief history, applications, types of 3D printers, 3D printing process, terminology, advantages and challenges)
  • An Introduction to Medical Devices & Overview of Medical Device Regulation in USA (what are medical devices, medical device classes and types of medical device submissions to US FDA)
  • 3D Printing of Medical Devices & FDA’s current thoughts (including technical design, manufacture and testing considerations for approval)
Why should you Attend
The Food and Drug Administration (FDA) is responsible for the approval of medical devices in the United States of America. Today 3D printing is used in a wide variety of applications, even for the manufacture of medical devices. So what are FDA’s current thoughts regarding the approval of 3D printed medical devices?

In this session, medical device manufacturers, software developers, engineers, validation experts, 3D printing raw material manufacturers and suppliers, regulatory and quality professionals, will be informed of FDA’s expectations regarding the design, manufacture and testing of 3D printed medical devices. Those interested in 3D printing technology will be well briefed too.

Who will Benefit
The following professionals from the Medical Device industry will benefit from this training:
  • Manufacturing
  • Production
  • Product Management
  • R&D
  • Software Developers and Vendors
  • Engineers
  • Validation Experts
  • 3D Printing Raw Material Manufacturers and Suppliers
  • Regulatory and Quality Professionals
  • Anyone Interested in 3D Printing Technology and / or Medical Devices
$375
Recorded Session for one participant
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  $500.00 Training CD
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  $600.00 Training USB Flash Drive
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How it works
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:
Rachelle D'Souza has licensed various medical and consumer products and facilities for start-ups and multi-national companies. Her expertise also includes clinical trial master file documentation, and the design and maintenance of globally compliant quality, safety/pharmacovigilance and medical information systems

At Regulatory Heights Inc., Rachelle continuously monitors the current regulatory environment and utilizes regulatory intelligence as a strategic business driver for her clientele. Her numerous articles on the latest international regulatory developments have been published in print and on-line by regulatory professional associations and industry magazines around the world.

Her versatility has enabled Regulatory Heights Inc. to support companies, in particular, start-ups with the licensing of their drugs and medical devices in international markets like Canada, USA, EU, China, Japan, Australia and New Zealand.
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