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6 Most Common Mistakes When Implementing ISO 13485 - Featured Image

6 Most Common Mistakes When Implementing ISO 13485

Companies must establish and maintain a quality management system in order to ensure they are produc...
Importance of Software Requirements in Product Development - Featured Image

Importance of Software Requirements in Product Development

Software and other requirements are critically important to medical device product development.
Everything You Need To Know To Perform Effective Root Cause Analysis - Featured Image

Everything You Need To Know To Perform Effective Root Cause Analysis

Picture this: something goes wrong with a medical device, and a complaint is issued. In a post-marke...
Eliminating Subjectivity and Guesswork with a Modernized Solution to Detecting Ear Infections - Featured Image

Eliminating Subjectivity and Guesswork with a Modernized Solution to Detecting Ear Infections

If you or your child have ever experienced ear infections, you know how difficult (and painful) they...
4 Facts That May Surprise You About FDA - Featured Image

4 Facts That May Surprise You About FDA

From creating product codes to following regulations, do you ever wonder what goes on inside the U.S...
Should you Swipe Right or Left on your Notified Body? - Featured Image

Should you Swipe Right or Left on your Notified Body?

How long have you been dating your Notified Body – “NB” for short? Is your eye beginning to wander? ...
Design History File Ready Ideation: An Innovative Approach to Product Development - Featured Image

Design History File Ready Ideation: An Innovative Approach to Product Development

As a medical device professional, do you know about Design History File Ready Ideation (DHFRI)?
Why I Used To Hate Risk Management (And 3 Ways to Change Your Mind Too) - Featured Image

Why I Used To Hate Risk Management (And 3 Ways to Change Your Mind Too)

I hate Risk Management. There, I said it. And I’m not the only one actually. We’re all thinking it. ...
Looking at the Sunset of FDA's Alternative Summary Reporting Program - Featured Image

Looking at the Sunset of FDA's Alternative Summary Reporting Program

The FDA recently decided to discontinue its alternative summary reporting program due to the allegat...
8 Most Common Mistakes to Avoid with 21 CFR Part 820 - Featured Image

8 Most Common Mistakes to Avoid with 21 CFR Part 820

Medical device companies selling or planning to sell into the US market should be familiar with FDA'...
Creating a Culture of Quality for Medical Device Companies - Featured Image

Creating a Culture of Quality for Medical Device Companies

Is creating a culture of quality a top priority at your MedTech company? But you’re not sure how or ...
Challenges with MedTech Innovation - Featured Image

Challenges with MedTech Innovation

The medical device industry strives to develop high quality and innovative products that will contri...

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