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Colour Riche
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Lip Color
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Greenlight Guru is the only Quality Management Software designed specifically for the medical device industry.


$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.

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.

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.

I really enjoy the new Greenlight Guru 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.

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.

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.

We've been using Greenlight Guru for nearly 5 years 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 backw...

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...

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 ...

We're all excited to have everything organized and to always know what the correct, most up-to-date version is.
Greenlight Guru has been instrumental for us moving so quickly through our ISO 13485 certification and I would highly recommend it.

A lot of times, if people don't understand quality systems, they think they just want to use paper because 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 custom...

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.

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.
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!
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...

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 ...

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...

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.

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

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.

The old world


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


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.

“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.

Explore our services



“Greenlight Guru has been instrumental for us, as a small team, while we efficiently navigate the quality management system process and with developing our FDA submission.”
- Ryan Nolan, Co-Founder / VP of Clinical Operations Photonicare

Are you interested in learning more about our Quality Management Software? Let’s take Greenlight Guru on a demo.


We surveyed medical device professionals to find out what challenges they are facing and what strategies they are prioritizing in 2021. Want to know what they shared?

Download the Report →

Featured Resources

Get to Market True Quality Summit Series

Whether you’re bringing your first device to market, or you have launched multiple already, our upcoming True Quality Summit Series is for you. There’s a variety of different topics designed to provide best practices for advancing throughout your product lifecycle and maintaining compliance across multiple markets.

An Exclusive Look at the New Changes to ISO 14971:2019 and ISO TR 24971:2019

A free, in-depth webinar covering the new changes to ISO 14971:2019, the international standard for medical device risk management, and its companion guidance document ISO TR 24971:2020.

A Complete Guide to Bringing a Medical Device to Market

A complete guide for medical device manufacturers looking for guidance on how to plan for a successful product launch and maintain regulatory compliance across global markets.