√ 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:
Save your seat in our upcoming live webinar!
Advisor & Former CEO of Glooko
Board member for Multiple Companies
Editorial Board Member
BNA Medical Device Law & Industry Report