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Upcoming Webinar: Tuesday February 19, 2019 at 11am PT / 2 pm ET

Are Your Products Ready for the FDA’s New Digital Health Pre-Cert Program?

Learn how digital health software regulations affect you
Register Now
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Part 1 of the Propel Medical Device Executive Webinar Series

√ Part 2, March 9: When's the best time for QMS?
√ Part 3, March 21: You bought some software. Now what?
√ Part 4, March 28: Live Product Demo of Propel QMS
√ Part 5, April 4 : Reduce Risk with Post-Market Surveillance and Product Complaints

Is your company developing or planning to develop a software product that meets the definition of a medical device?

On January 7, 2019, FDA published its draft working model for a new precertification program, to supplement its medical device approval process for software which functions as a medical device. It's a markedly different approach from how they regulate medical devices and new drugs. The FDA recognized that the traditional regulatory methodology is not well suited for the fast-paced, iterative-design development used for digital health software products.

Medical device experts Rick Altinger, Scott Thiel, and Bradley Thompson will outline the new digital health software regulations and answer your questions in this live webinar, such as:


Join us on Tuesday February 19, 2019 at 11am PT / 2 pm ET to learn:

  • Is my company eligible for the program?
  • What does it mean to be pre-certified?
  • What are the risks of non-participation?

Save your seat in our upcoming live webinar!


Click Below to Register on BrightTalk


Registration on the BrightTalk webinar platform

Rick Altinger

Advisor & Former CEO of Glooko
Board member for Multiple Companies

Bradley Thompson

Editorial Board Member
BNA Medical Device Law & Industry Report

Scott Thiel

Director
Navigant