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Recorded Webinar
How FDA Evaluates Your Quality Management System
timelapse 60 Min with 15 Min QnA of Q and A
Note:
This webinar occured in the past
Along with recorded webinar, copy of presentation slides will be shared
Recorded Webinar can be played unlimited times
Speaker/Presenter
Short Abstract
Once your company has successfully navigated the U.S. device clearance process, a Quality Management System (“QMS”) needs to be implemented before you can start marketing your product. Your QMS must contain all the requirements of FDA’s Quality System Regulations (“QSR”).
QSR imposes many requirements but contain little detail in how to implement them; however, failure to appropriately interpret these requirements could result in significant impact on your company, which may include temporary or permanent removal of your device from the market.
The presentation will cover the following areas:
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