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Case Study: Centese ditches paper-based QMS AND achieves FDA 510(k) clearance - Featured Image

Case Study: Centese ditches paper-based QMS AND achieves FDA 510(k) clearance

For many early-stage medical device companies, the default option when implementing a quality manage...
Case Study: How Innovere Accelerated Their Path To Market By Implementing Greenlight Guru’s Medical Device eQMS - Featured Image

Case Study: How Innovere Accelerated Their Path To Market By Implementing Greenlight Guru’s Medical Device eQMS

    Advanced magnetic resonance imaging (MRI) technology has become an important piece of healthcare...
Why Document Control Matters To Medical Device Companies - Featured Image

Why Document Control Matters To Medical Device Companies

As medical device professionals, we share a common goal of producing safe and effective medical devi...
Case Study: Lucerno Dynamics Has Simplified the 13485:2016 Certification Process With Greenlight Guru - Featured Image

Case Study: Lucerno Dynamics Has Simplified the 13485:2016 Certification Process With Greenlight Guru

In a world of rapidly changing regulatory requirements, achieving new certifications, such as ISO 13...
Case Study: How Greenlight Guru is Laying the Foundation for Success at Amnion Life - Featured Image

Case Study: How Greenlight Guru is Laying the Foundation for Success at Amnion Life

The majority of medical device companies operate on an emphasis of high quality outcomes and scalabi...
Quality, Fast, Cheap...Pick Two - Featured Image

Quality, Fast, Cheap...Pick Two

You may think you're saving the company money by using that "free" Excel spreadsheet to track design...
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...
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. 
Why There is a Need for Multi-Level Design Controls - Featured Image

Why There is a Need for Multi-Level Design Controls

We’ve added an exciting new update to our platform recently. The ability to manage multi-level desig...
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...
Understanding the New Requirements for QMS Software Validation in ISO 13485:2016 - Featured Image

Understanding the New Requirements for QMS Software Validation in ISO 13485:2016

As I am sure many of you know, the ISO 13485 standard was updated in 2016, which means the time to t...

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

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