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13 Tips For Audit Etiquette Every Medical Device Company Should Know - Featured Image

13 Tips For Audit Etiquette Every Medical Device Company Should Know

By Taylor Brown on August 11, 2019
I love audits. Seriously! It is a hybrid experience, like a kindergarten show-and-tell with a classi...
Why Document Control Matters To Medical Device Companies - Featured Image

Why Document Control Matters To Medical Device Companies

By Jon Speer on March 24, 2019
As medical device professionals, we share a common goal of producing safe and effective medical devi...
3 Real World Document Management Horror Stories - Featured Image

3 Real World Document Management Horror Stories

By Jon Speer on November 25, 2018
In the medical device world, it’s not uncommon to get hung up on documentation. “It takes too much t...
5 Myths Engineers Believe About Quality (and what is really true) - Featured Image

5 Myths Engineers Believe About Quality (and what is really true)

By Jon Speer on November 4, 2018
A well run medical device company is cross-functional in nature. Engineering, quality, regulatory, m...
The Importance of Good Document Management (And How To Do It) - Featured Image

The Importance of Good Document Management (And How To Do It)

By Jon Speer on September 16, 2018
The long-term success of medical device companies depends on the strength of their foundation. Good ...
Greenlight Guru Announces Advanced Document Management - Featured Image

Greenlight Guru Announces Advanced Document Management

By Nick Tippmann on September 5, 2018
Functionality enhances security while maintaining visibility and transparency in medical device qual...
Why Your Company Needs an Electronic Quality Management System - Featured Image

Why Your Company Needs an Electronic Quality Management System

By Jon Speer on August 12, 2018
It’s time to face facts: a paper-based quality management system is no longer an option. 
Why You Need To Stop Treating Risk Management & Design Controls as Checkbox Activities - Featured Image

Why You Need To Stop Treating Risk Management & Design Controls as Checkbox Activities

By Jon Speer on September 4, 2017
Understanding the relationship between product risk management and design controls is critical to th...
The Do’s and Don’ts of an FDA Inspection - Featured Image

The Do’s and Don’ts of an FDA Inspection

By Jon Speer on August 28, 2017
FDA has arrived at your premises…
13 Common Pitfalls to Avoid During Medical Device Product Development - Featured Image

13 Common Pitfalls to Avoid During Medical Device Product Development

By Jon Speer on July 9, 2017
Are you falling into some of the common traps that surround medical device product development?
What is a “Quality Data Source” for your CAPA Process? - Featured Image

What is a “Quality Data Source” for your CAPA Process?

By Jon Speer on April 17, 2017
There’s a phrase that the FDA states in their policies around CAPA, which elicits a few questions. T...
5 Places Paper Might Be Hiding in Your Medical Device Company - Featured Image

5 Places Paper Might Be Hiding in Your Medical Device Company

By Jesseca Lyons on July 11, 2016
A few weeks ago you left a big pile of paperwork (also known as your Document Change Order (DCO/ECO)...

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