Resource Library for Medical Device Professionals

7 total results. Show all resources.

This video series about the United States' medical device market shows you the process and identifies the key concepts to know before you begin.view all

동영상 | 24 minutes

This video about the United States medical device market gives an overview of the regulatory framework and registration process basics.view all

동영상 | 4 minutes

This video describes key aspects of the FDA UDI system, why it is necessary, benefits, and when and how device manufacturers need to comply.view all

동영상 | 5 min

This short video covers FDA classification, how to use the classification database, and useful tips for classifying your medical device.view all

동영상 | 7 min

In this video, we’ll take a look at 21 CFR Part 820, including an overview, key players, important sections, and how to maintain compliance.view all

동영상 | 11 min

In this video, we discuss what medical device companies should do (and what not to do) before, during, and after a random FDA audit. view all

동영상 | 4 minutes

Are you planning to export your device to other medical device markets? Most countries require you to have a physical presence in that market. If you do not have an office there, you can appoint an independent representative to meet this need.view all

동영상 | 7 min