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hello and thank you for investing some of your time in learning a little more about the medical device regulatory process in the United States over the next few videos in this series well take a look at some of the key aspects involved in bringing your medical device to market in the u.s. this course is broken up into seven sections or modules first well take a brief look at an overview of the United States market and regulatory framework next well examine the steps involved in classifying your medical device then well cover u.s. quality management system requirements followed by an overview of product testing and clinical data requirements will also discuss dossier preparation before moving on to how in-country representation works and finally well end with the section about device listing and maintenance this video is part of a series so you can use the thumbnails to skip around between topics if desired or just let them run in sequence ready lets get started with our first mod
