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Resource Library for Medical Device Professionals

6 total results. Show all resources.

ISO 13485:2016: Six Key Differences for Medical Device Companies

This short video covers the 6 biggest changes in the new ISO 13485:2016.

5 minutes
Jun 27, 2017

Introduction to European CE Marking for medical devices

This video about provides an overview of the regulatory framework and registration process basics for devices.

4 minutes
Sep 21, 2011

Introduction to ISO 13485 compliance for Europe

In this video, learn more about the background of EN ISO 13485, and the steps you can take to obtain ISO 13485 certification in Europe.

29 minutes
Nov 9, 2015

Introduction to Clinical Evaluation Reports (CER) for Europe

This video explores CERs, including what they are, why you need one, the research process, and contents and formatting.

4 minutes
Mar 15, 2016

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

In-Depth: Europe CE Marking Medical Device Approval and Compliance

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

21 minutes
Feb 8, 2012