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.

  • Automate design control and risk activities
  • Streamline quality documentation
  • Follow FDA, IVDR & ISO best practices
  • Achieve end-to-end traceability
  • Enhance team collaboration

 

  Astrego   RoverDX EKFDiagnostics Moirai Biodesign

 

Canterbury Sci Logo

HOW IVD MANUFACTURER STREAMLINED PRODUCTION AND IMPROVED QUALITY PROCESSES WITH AN INDUSTRY-SPECIFIC QMS

green-quotes If I were to quantify it, it's days of time saved. The cost of Greenlight Guru is repaid in efficiency."

Clive
Clive seymour
CEO at Canterbury scientific

 

Read the full story ➞

Case Study_ Canterbury Scientific - microsite download

 

About Greenlight Guru

green check Started in 2013 by medical device industry veterans
green check Only true cloud-based solution with fully connected Design Controls & Risk Management
green check Headquartered in Indianapolis, IN
green check Hundreds of customers on six continents

 

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The only Medical Device Solution To Be Named A Category Leader By G2 Crowd FOR TWO YEARS AND COUNTING
 
 
Customer Map
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 ...

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.

Eric Griffith
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.
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.
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.

Kyle Rose

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...

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.

Ryan Shelton

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...

Rian Wendling

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.

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...

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 ...

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!
Jed Johnson PhD
Greenlight Guru has been instrumental for us moving so quickly through our ISO 13485 certification and I would highly recommend it.
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.

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...

Greg Sommer

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

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.
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.

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

TAP INTO OUR EXPERIENCED GLOBAL PARTNER COMMUNITY

EXPERIENCED CONSULTING GUIDANCE AT EVERY POINT OF YOUR PRODUCT LIFE CYCLE

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!

PARTNER ECOSYSTEM

 

 

With Greenlight Guru, you can launch new devices faster, simplify compliance and streamline quality with a single source of truth that unites the team.

Greenlight Guru simplifies quality management and compliance. We keep our solution packages simple, too.
Our software packages are built to make it easy for you to adopt our platform. No configuration, no validation required.
Our onboarding process is easy and gets you learning from Day 1 in the application. Based on your needs and stage of company growth, we can find the package and support that best suits you and your goals.

Download our QuickStart Onboarding & Training Guide ➞

Customer-Onboarding-2021_Sample

 

  • $125,000 saved on average cost estimated per project
  • Improved culture during project cycle
  • 2.5 months faster to market

 

 

  • 402 hours saved on low value-added activities
  • Single source of truth for all quality processes
  • Better audit readiness

Emergo_600

Achieve QMS compliance in medical
device markets worldwide

Emergo by UL is a leading regulatory consulting firm specializing in global medical device and IVD compliance. Exclusive benefits for all customers:

#1 Medical Device Regulatory Consulting Firm in the World

  • Emergo Group Consultants ($0 per-user license cost) to act as
    users inside your Greenlight Guru Account
  • In-country representation for 25+ countries

Regulatory Affairs Management Suite 

  • One (1) year access to “Regulatory Intelligence” functionality
    inside of the Emergo Group RAMS platform 
  • One-time (1) discount toward any of the "Smart Builders"
    within the RAMS platform.

Value: $3,500 discount

 

NelsonLabs600

Global leader of microbiological
and analytical lab testing

Nelson Labs is the leading global provider of laboratory testing and expert advisory services for MedTech and pharmaceutical companies:

Regulatory Compliance Consulting - (3 Hours Included)

  • Regulatory support for submissions, product changes, or rejection notices
  • Test plans, protocols, and written justifications for method selection

Biological Evaluation Planning & Consulting - (3 Hours Included)

  • Review existing BEP for your device
  • Guidance on creating a world-class BEP
  • Eliminate unnecessary testing

Value: $2,650 discount

 

Nelson Labs Quote (3)