Resource Library for Medical Device Professionals

7 total results. Show all resources.

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 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 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

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

Video | 11 min