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Choosing an EU Authorised Representative (EC REP) for Medical Device Regulatory Issues - Featured Image

Choosing an EU Authorised Representative (EC REP) for Medical Device Regulatory Issues

By EMERGO by UL on October 15, 2021
So you're ready to export to Europe. You've tackled the myriad tasks associated with packaging, mark...
European Authorized Representative for Medical Device Companies - Featured Image

European Authorized Representative for Medical Device Companies

By EMERGO by UL on October 12, 2021
ANSWERED ON THIS PAGE: What are the responsibilities of an EU Authorized Representative (EC REP)? Ca...
How to Structure your Medical Device Technical File - Featured Image

How to Structure your Medical Device Technical File

By Jon Speer on April 18, 2021
The medical device technical file is a must-have document for devices to be sold in the EU marketpla...
Top 100 Medical Device Acronyms & Terminology You Need to Know - Featured Image

Top 100 Medical Device Acronyms & Terminology You Need to Know

By Jon Speer on July 19, 2020
In the medical device industry, knowledge is power. Your knowledge of medical device terminology emp...
EU MDR Delay: How to Plan Beyond the Coronavirus Pandemic - Featured Image

EU MDR Delay: How to Plan Beyond the Coronavirus Pandemic

By Jon Speer on May 3, 2020
The EU Medical Device Regulation (MDR) has been a source of stress for medical device companies arou...
5 Steps for Getting your CE Marking with EU MDR Requirements - Featured Image

5 Steps for Getting your CE Marking with EU MDR Requirements

By Tom Rish on January 12, 2020
It has long been thought that the quickest path to market for medical device manufacturers is to acc...
Should you Swipe Right or Left on your Notified Body? - Featured Image

Should you Swipe Right or Left on your Notified Body?

By Michelle Lott on July 7, 2019
How long have you been dating your Notified Body – “NB” for short? Is your eye beginning to wander? ...

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