All-in-one, easy-to-use quality solution that simplifies regulatory compliance and provides a single source of truth by connecting the management of all product development, regulatory, and quality processes from documentation and design controls to submission and ongoing compliance.
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Started in 2013 by medical device industry veterans |
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Only true cloud-based solution with fully connected Design Controls & Risk Management |
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Headquartered in Indianapolis, IN |
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Hundreds of customers on six continents |
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 ...
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.
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...
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.
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...
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.
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 ...
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.
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...
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.
Discover the most highly-trained medical device consultants in the world to guide you along your path to market.
From developing the regulatory plan to product development, submission, testing, packaging, through product launch & post-market surveillance...we will connect you with 100+ experienced consulting firms around the globe to enable you to get more done, faster, and with less risk!
BEST QMS SOFTWARE: ULTIMATE GUIDE TO COMPARING QUALITY MANAGEMENT SYSTEM SOLUTIONS |
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15 QUESTIONS TO ASK QMS SOFTWARE VENDORS IN THE MEDICAL DEVICE INDUSTRY |
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5 DO'S AND DON'TS WHEN CHOOSING A QMS SOLUTION FOR YOUR MEDICAL DEVICE COMPANY |
The best QMS software comparison guide for medical device companies that will help you choose a quality management system solution that strategically benefits your product and company. | Know what questions to ask software vendors that give your medical device company the necessary information to consider when selecting a QMS software solution. | A guide to the top 5 recommended best practices that medical device companies should consider when choosing a quality management system (QMS) solution. |
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SIMILARITIES & DIFFERENCES BETWEEN IN VITRO DIAGNOSTIC (IVD) DEVICES & MEDICAL DEVICES |
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ISO 13485 - ULTIMATE GUIDE TO THE QUALITY MANAGEMENT SYSTEM (QMS) FOR MEDICAL DEVICES |
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QUALITY MANAGEMENT FOR IVD DEVICES VS MEDICAL DEVICES |
Understand the key similarities and differences between the two types of devices and recommendations for IVD manufacturers when it comes to regulatory compliance and their quality system. |
Greenlight Guru eQMS platform automates regulatory compliance with ISO 13485:2016, FDA, ISO 14971, so companies can focus on true quality of devices. |
Learn how managing quality for in vitro diagnostic devices is compared to medical device, industry best practices and tools that manufacturers can use to produce high-quality products that are safe and effective for end-users. |
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We make it easy for you to connect with a global ecosystem of experienced industry experts and certified Greenlight Guru consultants that will point you in the right direction and ultimately set you up for a successful product launch.
Emergo by UL is a leading regulatory consulting firm specializing in global medical device and IVD compliance. Exclusive benefits for all customers:
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