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How to Build a Medical Device Business Case in 5 Easy Steps - Featured Image

How to Build a Medical Device Business Case in 5 Easy Steps

In business, so much of success depends on timing. A product launches too early and is misunderstood...
8 Questions That Define Your Medical Device User Needs - Featured Image

8 Questions That Define Your Medical Device User Needs

When people talk about design controls, they often place a lot of emphasis on design inputs and outp...
30/60/90 Day Plan to Making an Impact as a New QA/RA Manager - Featured Image

30/60/90 Day Plan to Making an Impact as a New QA/RA Manager

Starting a new job is always a little stressful. But when you’re a new QA/RA Manager, there’s even m...
Explaining UDI Requirements for GUDID and EUDAMED - Featured Image

Explaining UDI Requirements for GUDID and EUDAMED

Recent numbers from the World Health Organization indicate there are at least 2 million different ty...
3 Common Misconceptions About Medical Device Packaging - Featured Image

3 Common Misconceptions About Medical Device Packaging

If you asked people what comes to mind when you say designing a medical device, you’re likely going ...
QMSR (Quality Management System Regulation) Explained: What FDA QSR & ISO 13485 Harmonization Means for Medical Device Companies - Featured Image

QMSR (Quality Management System Regulation) Explained: What FDA QSR & ISO 13485 Harmonization Means for Medical Device Companies

On February 23, 2022, FDA released its proposed rule for the new Quality Management System Regulatio...
Design vs. Utility Patents: Choosing the Right One for Your Device - Featured Image

Design vs. Utility Patents: Choosing the Right One for Your Device

If you go through the rigors of designing and developing a medical device, it only makes sense that ...
How Do FDA Medical Device Recalls Work? - Featured Image

How Do FDA Medical Device Recalls Work?

For medical device companies, few things are as valuable as the public’s trust.
Best Practices for an Effective Medical Device Design Transfer Process - Featured Image

Best Practices for an Effective Medical Device Design Transfer Process

If you’re looking for information on design controls and product development, you can find a practic...
Switching to an Electronic Device History Record (eDHR): What Medical Device Companies Should Know - Featured Image

Switching to an Electronic Device History Record (eDHR): What Medical Device Companies Should Know

Your device history record (DHR) is one of the final forms of documentation you’ll need before your ...
UDI: Everything You Need to Know About Unique Device Identifiers for the FDA - Featured Image

UDI: Everything You Need to Know About Unique Device Identifiers for the FDA

Every aspect of the medical device industry needs to be built on the highest standards for quality a...
ISO 11607: A Primer on Packaging for Terminally Sterilized Medical Devices - Featured Image

ISO 11607: A Primer on Packaging for Terminally Sterilized Medical Devices

For many medical devices, sterilization is the final step in the manufacturing process before they’r...

The Greenlight Guru Medical Device Blog

Providing you actionable tips, best practices and insights for better medical device quality, compliance and product development.

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