FDA Regulation, 3D Printing and Medical Devices


Rachelle D'Souza is Keynote Speaker at Compliance key Inc.She is 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 articl....

Overview

This webinar on 3D printing will cover FDA's expectations regarding the design, manufacture, testing and approval of 3D printed medical devices.

Why should you attend this webinar?

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.

Areas Covered in the Session:

  • 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)

Who can Benefit:

  • 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



Webinar Id: LSHCRD002

Training Options:

Duration: 90 mins

 06/20/2017

 12:30 AM PST | 03.30 PM EST

 Single Attendee: [Only for one participant]

 $179 (Live)                    $304 (Live + Recorded)

 Multiple Attendee: [For a group of 2-5 participants]

 $363 (Live)                    $488 (Live + Recorded)

 Corporate Attendee: [For a group of 6-10 Participants]

 $726 (Live)                    $945 (Live + Recorded)

 Recorded: [Six month unlimited access]

 $217(Single Attendee)  $599 (Unlimited Attendee)

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