FDA Regulation, 3D Printing and Medical Devices

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?

This webinar on 3D printing will cover FDA’s expectations regarding the design, manufacture, testing and approval of 3D printing medical devices. In this medical device compliance training, 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 :

• 3D Printing
  • Brief History
  • Applications
  • Types of 3D printers
  • 3D printing process
  • Terminology
  • Advantages and Challenges
• US Medical Device Regulation
  • Device Classifications
  • Related Latest Regulations
  • Types of device submissions to US FDA
• 3D Printing of Medical Devices
  • FDA’s current thoughts
  • Technical design
  • Manufacturing
  • Testing considerations for approval

Who Should Attend:

• Manufacturing Departments
• Production Departments
• Product Management
• R&D Departments
• Regulatory Departments
• Quality Departments
• Software developers and vendors
• Engineering Departments
• Validation experts
• 3D printing raw material manufacturers and suppliers
• Anyone interested in 3D printing technology and / or medical devices

Course Director: RACHELLE D'SOUZA

Rachelle D’Souza, CEO of Regulatory Heights Inc., has successfully licensed various medical and consumer products and facilities with international regulatory authorities / agencies for multinational and start-up 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.