Resource Library for Medical Device Professionals

7 total results. Show all resources.

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.watch now

Video | 29 minutes

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

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

Video | 5 minutes

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

Video | 4 minutes

In this video, learn about medical device labeling symbols, their meanings, and how they communicate important product information.watch now

Video | 11 min

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

Video | 21 minutes