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Resource Library for Medical Device Professionals

8 total results. Show all resources.
United States

In Depth: US FDA Medical Device Registration and Compliance

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

24 minutes
Jan 25, 2012
United States

Introduction to US FDA Medical Device Regulatory Process

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

4 minutes
Sep 21, 2015
United States

Introduction to the UDI System in the USA

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

5 min
Nov 23, 2015
United States

In Depth: The US FDA 510(k) Clearance Process

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

8 minutes
Apr 23, 2018
United States

Overview of the USA FDA Classification Process

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

7 min
Jan 12, 2016
United States

In Depth: 21 CFR Part 820 - FDA Quality System Regulation

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.

11 min
May 18, 2016
United States

How to Prepare for an FDA Inspection

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

4 minutes
Aug 9, 2016
United States

What To Expect From Your Regulatory Representative

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.

7 min
Nov 22, 2016