Developing a flexible and adaptable regulatory strategy is key to supporting the development of safe and effective 3D printed medical devices that help improve the quality of life for patients. The complexity of developing medical devices using 3D printing technology is challenging, given the need to navigate the latest U.S. regulatory pathways. This webcast will discuss the U.S. pathway for approval and will highlight the global regulatory landscape for obtaining approval of 3D printed devices in Europe, Australia, and Canada.
Learning objectives for attendees include:
- Understand the history of regulations governing the development of 3D printed medical devices and the impact of warning letters that shaped the regulations.
- Learn about the U.S. pathway for approval and how it differs for Europe, Canada, and Australia.
- Obtain insights on how the regulations need to change to address ongoing industry challenges for getting products to market.
This event is brought to you by the RAPS Colorado and San Francisco Bay Area Chapters to encourage knowledge sharing and community development. RAC holders may claim 1.0 RAC recertification credit.
Learning Level: Intermediate
Intermediate: Content is designed based upon the assumption that individuals have basic knowledge of the topic(s) and/or demonstrated competence related to the topic(s). Higher-level concepts are introduced during lectures; exercises requiring synthesis and/or application of concepts are incorporated into the activity.
RAPS membership provides vital information for regulatory professionals and a place for networking and invaluable connections. Now is a great time to explore the many benefits to RAPS membership, including the Member Knowledge Center and our award-winning, private online community, Regulatory Exchange. Find out more about RAPS membership today.
How Do Webcasts Work?
For the best webcast experience, please use the Google Chrome browser. RAPS webcasts are also mobile- and tablet-accessible for your convenience. Registrants will receive instructions on how to log in 24 hours before the start of the webcast. A live Q&A portion with the speaker will follow the presentation.
Kim Torluemke, RAC, CEO, KT Regulatory Consulting, LLC
Thank you to our Platinum Chapter Sponsors:
RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation.
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