This episode has been published on September 4th, 2019
Welcome to the 26th episode of Automating Quality. Mandy Gervasio is your host, and she’s on a mission to bring you hot industry topics with her fellow life sciences partners and friends!
Today’s show is focusing on a topic that has yet to be discussed on the show thus far, and that is the medical device industry and current hot trends from a regulatory perspective! Automating Quality has taken a look at regulatory trends from a broader perspective, but this is the first time they will be diving deep into the current happenings in the device space.
This episode will shed light on some key areas in FDA shift and focus; provide information on innovating trends that are transforming this niche; as well as changes to medical device regulations, setting new precedents that the industry is being held accountable for adopting.
[:29] About today’s episode!
[1:20] Mandy explains how the FDA is using science to help innovate and accelerate the medical device industry, as well as why the FDA is so invested in pioneering enhancements to this specialized area of the life sciences industry.
[3:30] The context of use on MDDT tools.
[4:30] The types of categories that fall under the MDDT Program and how these categories are assessed.
[7:55] Have new regulations been implemented that impact the medical device manufacturers?
[10:52] Mandy explains some of the key impacts of these new regulations.
[15:02] Mandy thanks listeners for tuning in!
[16:10] If you have any questions or suggestions for future episodes, you can contact Mandy at Mandy.Podcast@Solabs.com.
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