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15 Reasons Why Medical Device Companies Choose Greenlight Guru - Featured Image

15 Reasons Why Medical Device Companies Choose Greenlight Guru

The medical device industry has been undergoing a major shift for the past 20 years, and now that sh...
The Importance of Good Document Management (And How To Do It) - Featured Image

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

The long-term success of medical device companies depends on the strength of their foundation. Good ...
Why the FDA Case for Quality Matters - Featured Image

Why the FDA Case for Quality Matters

When I first learned about the FDA’s Case for Quality initiative, I immediately wanted to learn more...
21 CFR Part 11: A Complete Guide - Featured Image

21 CFR Part 11: A Complete Guide

Medical device companies that wish to sell their devices in the US and EU must implement a quality m...
Why Your Company Needs an Electronic Quality Management System - Featured Image

Why Your Company Needs an Electronic Quality Management System

It’s time to face facts: a paper-based quality management system is no longer an option. 
How a Partnership with Greenlight Guru Helped Rook Quality Systems Grow 5X in Two Years - Featured Image

How a Partnership with Greenlight Guru Helped Rook Quality Systems Grow 5X in Two Years

Have you ever wondered what partnering with Greenlight Guru could mean for your business? We have a ...
How SOLIUS Went from Scratch to an eQMS and ISO 13485:2016 Certification - Featured Image

How SOLIUS Went from Scratch to an eQMS and ISO 13485:2016 Certification

It can be challenging for small companies to navigate the medical device regulatory pathways, especi...
MYOLYN Gains 510(k) Clearance 48% Quicker Than Average Using Greenlight Guru - Featured Image

MYOLYN Gains 510(k) Clearance 48% Quicker Than Average Using Greenlight Guru

For any startup medical device company, the road to FDA 510(k) clearance can be fraught with any num...
What Does a Risk-Based QMS Mean? - Featured Image

What Does a Risk-Based QMS Mean?

What exactly is a risk-based QMS?
How to Switch to eQMS Software When You're Just Using Paper - Featured Image

How to Switch to eQMS Software When You're Just Using Paper

How reliable is your paper-based quality management system? This situation plays out in medical devi...
5 Places Paper Might Be Hiding in Your Medical Device Company - Featured Image

5 Places Paper Might Be Hiding in Your Medical Device Company

A few weeks ago you left a big pile of paperwork (also known as your Document Change Order (DCO/ECO)...
What It Means to Join the Greenlight Guru Family - Featured Image

What It Means to Join the Greenlight Guru Family

When your medical device company makes the decision to go with Greenlight Guru, you might think that...

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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