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How to Create a Clinical Evaluation Report (CER) under MEDDEV & MDR (Part 4 of 4) - Featured Image

How to Create a Clinical Evaluation Report (CER) under MEDDEV & MDR (Part 4 of 4)

If you plan on selling a medical device in the European Union, then you should plan on writing a cli...
Performing Data Analysis for Your Medical Device’s Clinical Evaluation (Part 3 of 4) - Featured Image

Performing Data Analysis for Your Medical Device’s Clinical Evaluation (Part 3 of 4)

All of your hard work has been leading up to this. So far in the clinical evaluation process, you’ve...
The Clinical Evaluation Literature Review Process: Identifying and Appraising Clinical Data (Part 2 of 4) - Featured Image

The Clinical Evaluation Literature Review Process: Identifying and Appraising Clinical Data (Part 2 of 4)

A successful clinical evaluation hinges on your ability to find and appraise the data you’ll need to...
Clinical Evaluation of a Medical Device: Creating a Process and Establishing Equivalency (Part 1 of 4) - Featured Image

Clinical Evaluation of a Medical Device: Creating a Process and Establishing Equivalency (Part 1 of 4)

To obtain a CE marking and market your medical device in the EU, you’ll first need to perform a clin...
Transitioning to IVDR: The New EU Regulation for In Vitro Diagnostic Medical Devices - Featured Image

Transitioning to IVDR: The New EU Regulation for In Vitro Diagnostic Medical Devices

In the European Union, in vitro diagnostic (IVD) devices are governed by a specific set of regulatio...
Explaining IVDR Classification for In Vitro Medical Devices - Featured Image

Explaining IVDR Classification for In Vitro Medical Devices

The In Vitro Diagnostic Regulation (IVDR), which concerns in vitro diagnostic medical devices in the...
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

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

ANSWERED ON THIS PAGE: What are the responsibilities of an EU Authorized Representative (EC REP)? Ca...
3 FAQ about CE Marking Medical Device Manufacturers Want to Know - Featured Image

3 FAQ about CE Marking Medical Device Manufacturers Want to Know

If you take a close look at many of the objects you use each day—keyboards, monitors, headphones, an...
How to Structure your Medical Device Technical File - Featured Image

How to Structure your Medical Device Technical File

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

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

The EU Medical Device Regulation (MDR) has been a source of stress for medical device companies arou...

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