Medical Device Quality, Regulatory and Product Development Blog | Greenlight Guru

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

By Nick Tippmann on March 29, 2019

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

By Nick Tippmann on March 28, 2019

Advanced magnetic resonance imaging (MRI) technology has become an important piece of healthcare...

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

By Nick Tippmann on March 13, 2019

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

By Nick Tippmann on March 12, 2019

The majority of medical device companies operate on an emphasis of high quality outcomes and scalabi...

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

By Connor Remaley on July 10, 2018

Have you ever wondered what partnering with Greenlight Guru could mean for your business? We have a ...

How Priority Designs Used Greenlight Guru to Gain ISO 13485:2016 Certification

By Nick Tippmann on May 25, 2018

We have many different types of companies using Greenlight Guru to help them create a compliant qual...

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

By Nick Tippmann on May 25, 2018

It can be challenging for small companies to navigate the medical device regulatory pathways, especi...

How SimplicityMD Is Leveraging Technology Plus a Lean Approach to Help Get Their Devices to Market Faster

By Nick Tippmann on March 29, 2017

In today’s episode we continue our series on new breed medical device company stories. We talk with ...

How a New Breed of Medical Device Companies Is Leveraging Technology to Get More Done with Less Resources

By Nick Tippmann on November 8, 2016

Zebra Medical Technologies is part of a new breed of medical device companies. They understand the r...

Recovery Force Accelerates Their Product Development Efforts Using Greenlight Guru [Case Study]

By Nick Tippmann on June 22, 2016

With its innovative technology in the highly competitive and expanding compression therapy market, i...

The Greenlight Guru Advantage - More Than QMS Software [Customer Video Testimonial]

By Jon Speer on December 28, 2015

What do you know about Greenlight Guru? Your first thought may be that Greenlight Guru is a software...

LITG Case Study: Easily Documenting Design Controls to Accelerate Product Development

By Jon Speer on December 3, 2015

"Medical device companies must document Design Controls, yet most struggle with this. Greenlight...

Greenlight Guru Medical Device Blog