Below is the recording of the webinar providing key insights and guidance regarding these new regulations. If you would like to learn more about the nuances of these new regulations, how they might impact your premarket submission, or how to develop efficient documentation utilizing the optimal tools and templates to comply with regulations in domestic and international markets, please feel free to schedule a call with Kyle and Andrew using the additional link below.
Rook QS Webinar: First FDA Software Updates in 16 Years
On Monday, November 22nd, Rook’s Kyle Rose and Andrew Wu, two of the industry’s foremost experts on quality and regulatory strategy in the software space, presented a webinar addressing the first new regulations the FDA has released for Content of Premarket Submissions for Device Software Functions in over 16 years, and how they might impact SaMD or SiMD premarket submissions.