Resource Library for Medical Device Professionals

8 total results. Show all resources.

In this 8-minute video, we discuss the steps you should take to prepare and submit a 510(k) to the US FDA.watch now

Video | 8 minutes

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

Video | 24 minutes

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

Video | 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.watch now

Video | 5 min

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

Video | 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.watch now

Video | 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. watch now

Video | 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.watch now

Video | 7 min