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?
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.
CEO & President ,
Regulatory Heights Inc.
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.
- Product Management
- Software Developers and Vendors
- Validation Experts
- 3D Printing Raw Material Manufacturers and Suppliers
- Regulatory and Quality Professionals
- Anyone Interested in 3D Printing Technology and / or Medical Devices