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7 Project Management Tips - Featured Image

7 Project Management Tips

When I began my medical device career, I started as a product development engineer. Part of the role...
Project Management for Product Development of Medical Devices - Featured Image

Project Management for Product Development of Medical Devices

How should you approach project management for medical device product development ? Stop managing yo...
What’s the Difference Between Clinical Evaluation and Clinical Investigation? - Featured Image

What’s the Difference Between Clinical Evaluation and Clinical Investigation?

Within the myriad of regulations and standards governing medical devices, there are a number of simi...
IEC 62366 Explained: What You Need To Know About Usability Engineering - Featured Image

IEC 62366 Explained: What You Need To Know About Usability Engineering

Usability engineering (UE)—or human factors engineering (HFE), as it’s also known—is focused on desi...
Medical Device 3D Printing: Should You Make the Move? - Featured Image

Medical Device 3D Printing: Should You Make the Move?

The medical device industry has grown immensely over the past several decades. But with new technolo...
Clinical Testing for Medical Devices: What US Manufacturers Need to Know - Featured Image

Clinical Testing for Medical Devices: What US Manufacturers Need to Know

Clinical testing of medical devices is a critically important step in ensuring the safety and effica...
Assessing the Global Regulatory Landscape - Featured Image

Assessing the Global Regulatory Landscape

With medical device regulations tightening around the world, especially in Europe, it's important to...
Ultimate Guide to QA & RA in Medical Device 3D Printing - Featured Image

Ultimate Guide to QA & RA in Medical Device 3D Printing

This document aims to guide users in the medical device industry through every stage of the product ...
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...
Software as a Medical Device: Definitions, Examples & Regulatory Framework - Featured Image

Software as a Medical Device: Definitions, Examples & Regulatory Framework

Software as a Medical Device (SaMD) is a technology with limitless possibilities. In the hands of ta...
Quality Insights from a 40+ Year Veteran of the Medical Device Industry - Featured Image

Quality Insights from a 40+ Year Veteran of the Medical Device Industry

In this episode of the Global Medical Device Podcast, Jon Speer talks to Herschel “Buzz” Peddicord, ...
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...

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