FDA has partnered with Greenlight Guru to spread awareness for FDA’s Case for Quality program and regulatory paradigm shift.

TRUE QUALITY IS WITHIN REACH

Greenlight Guru is the only Quality Management Software designed specifically for the medical device industry.

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LEADING MEDICAL DEVICE COMPANIES IN MORE THAN 600 CITIES IN 50 COUNTRIES ON 6 CONTINENTS IMPLEMENT THEIR QUALITY CULTURE USING OUR SOFTWARE

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David Narrow

I've been thrilled with my experience working with Greenlight Guru. I am new to quality systems and compliance, and Greenlight Guru has made this transition very easy. The well-organized user interface and tracking features make the software simple and worry-free; I genuinely recommend it to anyone in the indus...

Dan Holton

I believe the quality system I've instituted actually gives me a competitive advantage against a lot of the large companies I used to work for.

Greg Sommer

Using the Greenlight Guru system has enabled us to better implement our quality system across the company and accelerate our product development.

Kayla Rodriguez Graff

We are ecstatic about our partnership with the Greenlight Guru team and the performance of their cutting-edge solutions. The sleek design eloquently and easily guides us through a traditionally complicated, intense and error-prone process. As a young company, this partnership with Greenlight Guru has already saved u...

Jason Wandersee
I can attest - great company, great people, great solution. They take a significant amount of risk out of medical device companies by creating transparency in the QMS and efficient access for all constituents. Keep up the great work!
Schelte Post

Your software helped us tremendously in the last few months of 2017, during which we had an important ISO 13485:2016 audit. This obviously reflected on the auditors: it was very easy to show them in what phase every project was, but also to simply show every piece of documentation we have. In the auditors conclusion...

Matt Bellman PhD
I can't tell you how much of a burden on me has been lifted by working with Greenlight Guru. You're a life saver.
Rian Wendling
Rian Wendling, Director of Regulatory Affairs
SimplicityMD

Greenlight Guru has made the design control and risk management process extremely easy to understand and explain to people not familiar with the process and helped them to understand how all of the steps are linked. It has also made it significantly easier to get documentation reviewed and approved.

Kate Montgomery
We're all excited to have everything organized and to always know what the correct, most up-to-date version is.
Evan Jones

This is my first time going through a medical device product development process. I've heard about all the challenges with Design Control. With Greenlight Guru, I know what to do and when to do it. Documenting Design Controls is really easy with this software.

Michelle Zwernemann
The traceability matrix was a huge selling point since I was in the process of trying to train my team on design controls and they had generated spreadsheets that were extremely impenetrable. Also I don't have to run after people to get documents approved. Everyone knows where to look for stuff so I don't have to dig t...
Donna Philput

As a design firm, our ISO 13485 certification is a competitive advantage. Greenlight Guru made getting it easy. Our designers aren't accustomed to being under a quality system, but your simple interface made it possible to adopt. It's actually working.

Allan Katz
Medical device companies must document Design Controls, yet most struggle with this. Greenlight Guru makes this so much easier for us. Another HUGE headache for medical device companies like ours is document management. And Greenlight Guru helps us take care of this too.
Kyle Rose

A lot of times, if people don't understand quality systems, they think they just want to use paper becaue it presents as the cheaper option, but they fail to evaluate the total cost of ownership and impact on the business. The biggest differentiator was that it was all web based and didn't need any customi...

Adnan Ashfaq

When it comes to the way they have designed the fully integrated workflows exclusively for medical device and continue to innovate with new releases, I'd call them the Tesla of medical device eQMS software.

Linda  Cox

We adopted Greenlight Guru 18 months ago to build our QMS. We recently passed our ISO 13485 Stage 2 audit, due in part to the ability to demonstrate a comprehensive matrix of risk and design controls. Demonstrating our QMS using a tool like GG was fundamental in this achievement. I'll also say that the team at ...

Linda Cox

I was actually a little nervous going into the audit, because it seemed too effortless. I've worked in QA at a Fortune 500 company with a custom solution. Your flow is better. It saves time and it doesn't break up my thought process. With Greenlight Guru I'm able to focus on quality.

Ryan Shelton
We've been using Greenlight Guru for the better part of a year now and it really simplifies quality management. It's very easy to get all of our team on the same page and effortlessly trace various efforts through the system. The Greenlight Guru team is one of the best I've ever worked with. They bend over backwards to...
Mike Fisher

Having 20 years of medical device experience, I have worked with large and elaborate design controls and small and lean design controls. I have also seen the disaster resulting from the absence of appropriate design controls. Greenlight Guru is exactly big enough to ensure compliance but small enough to be easily ...

Jed Johnson PhD
Greenlight Guru has been instrumental for us moving so quickly through our ISO 13485 certification and I would highly recommend it.
Ronny Bracken
$20 million might not seem like a lot of money to you, but if you get a $20 million haircut on your valuation because your design controls and quality system aren't up to speed, I guarantee you that's going to hurt. We use Greenlight Guru to avoid that haircut.
Eric Griffith
I really enjoy the new Greenlight Guru Grow product! Especially the customer feedback workflow. I like the similarities in workflows between CAPA, nonconformances, audits, and customer feedback. This will improve our abilities to better manage quality events and make better quality decisions.
Gabriel Sanchez

We dug deeper to see how other friends we knew were handling their QMS needs and after adding up time, consultant fees, etc. we felt Greenlight Guru was the right tool for the job.

“Wonderful eQMS and Team! ”
April 26, 2018
The old world

DISCONNECTED SYSTEMS DISTRACT YOUR QUALITY FOCUS AND LEAD TO INCREASED RISK.

Relying on a general purpose or paper-based QMS for your medical device quality system leaves you exposed to compliance complexities and regulatory roulette.

The world with Greenlight Guru

A CONNECTED QUALITY ECOSYSTEM LETS YOU SEE WHAT YOU’VE NEVER SEEN.

Our software connects disparate processes, sources, people, and data for the first time ever. Increased visibility smooths your path to compliance and puts True Quality within reach.

Solius-quote-photo
“In my previous experience, document, risk, and design control matrices were three different systems and I had to painstakingly move between all three. With Greenlight Guru they are seamlessly linked.”
James Wu, the Quality Engineer, Solius

Greenlight Guru Solutions

Quality Management Software. Industry-Leading Expertise.
Our Premarket Quality Management Software helps you set the right foundation to bring safer, high-quality medical devices to market faster.

Our Postmarket Quality Management Software provides visibility that decreases risk so you can advance the success of your medical devices.

Our Quality Management Experts help you establish and advance a quality culture throughout your entire device lifecycle.

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GLOBALLY TRUSTED BY INNOVATIVE MEDICAL DEVICE COMPANIES

Gabriel Sanchez
Gabriel Sanchez, CEO
Zebra Medical Technologies

We dug deeper to see how other friends we knew were handling their QMS needs and after adding up time, consultant fees, etc. we felt Greenlight Guru was the right tool for the job.

David Narrow
David Narrow, CEO
Sonavex, Inc.

I've been thrilled with my experience working with Greenlight Guru. I am new to quality systems and compliance, and Greenlight Guru has made this transition very easy. The well-organized user interface and tracking features make the software simple and worry-free; I genuinely recommend it to anyone in the indus...

Greg Sommer
Greg Sommer, CEO & Co-founder
Sandstone Diagnostics, Inc.

Using the Greenlight Guru system has enabled us to better implement our quality system across the company and accelerate our product development.

Linda  Cox
Linda Cox, SVP QA/RA
beneSol

We adopted Greenlight Guru 18 months ago to build our QMS. We recently passed our ISO 13485 Stage 2 audit, due in part to the ability to demonstrate a comprehensive matrix of risk and design controls. Demonstrating our QMS using a tool like GG was fundamental in this achievement. I'll also say that the team at ...

Ryan Shelton
Ryan Shelton, CEO
PhotoniCare
We've been using Greenlight Guru for the better part of a year now and it really simplifies quality management. It's very easy to get all of our team on the same page and effortlessly trace various efforts through the system. The Greenlight Guru team is one of the best I've ever worked with. They bend over backwards to...
Kayla Rodriguez Graff
Kayla Rodriguez Graff, Co-Founder & COO
SweetBio

We are ecstatic about our partnership with the Greenlight Guru team and the performance of their cutting-edge solutions. The sleek design eloquently and easily guides us through a traditionally complicated, intense and error-prone process. As a young company, this partnership with Greenlight Guru has already saved u...

Mike Fisher
Mike Fisher, Director of Product Development
GCMI (Global Center for Medical Innovation)

Having 20 years of medical device experience, I have worked with large and elaborate design controls and small and lean design controls. I have also seen the disaster resulting from the absence of appropriate design controls. Greenlight Guru is exactly big enough to ensure compliance but small enough to be easily ...

Ronny Bracken
Ronny Bracken, COO
Nanofiber Solutions
$20 million might not seem like a lot of money to you, but if you get a $20 million haircut on your valuation because your design controls and quality system aren't up to speed, I guarantee you that's going to hurt. We use Greenlight Guru to avoid that haircut.
Jason Wandersee
Jason Wandersee, Former CEO
Medisiss
I can attest - great company, great people, great solution. They take a significant amount of risk out of medical device companies by creating transparency in the QMS and efficient access for all constituents. Keep up the great work!
Allan Katz
Allan Katz, CEO & President
Long Island Technology Group
Medical device companies must document Design Controls, yet most struggle with this. Greenlight Guru makes this so much easier for us. Another HUGE headache for medical device companies like ours is document management. And Greenlight Guru helps us take care of this too.
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Are you interested in learning more about our Quality Management Software? Let’s take Greenlight Guru on a demo.

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Featured Resources

FDA's Case for Quality: Simplifying the regulatory activities (Part 4 of 4)

Quality VS Compliance Metrics & What's Next for FDA's Case for Quality Pilot (Part 3 of 4)

FDA's Case for Quality: Voluntary Program and Status Update (Part 2 of 4)