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We searched for a digital solution to see if one was available after being told that only paper-based systems would satisfy FDA. We found Greenlight Guru and have been delighted with both the product and the service. Greenligh Guru gives us a digital QMS so that we can safely launch our first four products. We feel confident our system can withstand any FDA audits.
The DC and Risk matrices make Greenlight Guru a great software for medical device companies. The ability to link the design controls and risk elements together allow companies to develop safe and effective devices. The application also allows our teams to work together from different locations in order to accommodate everyone's schedules! The Greenlight Guru software keeps a log of all changes made in the system. This means each time a user views, edits, approves, rejects, etc. an input in the software, the data is captured and can be pulled for reference. This allows for traceability...
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The software allows me to mitigate my regulatory and compliance risk, I have been able to implement a world class eQMS that rivals the largest companies in med device. Greenlight has the best in class support, it is both software and service.
Real time reviewing and publishing of quality documents. GUI of website makes it very easy to navigate without any hassle.
The support at Greenlight Guru has been incredible. There is live chat available and any question [is answered] in a matter of minutes! This extends beyond just how does system support. Greenlight Guru is able to answer questions related to ensuring that your system is compliant to the necessary standards required for medical devices.
Easy to upload, organize, and find documents
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.
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.
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 ...
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 ...
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.
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.
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...
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.
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.
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.
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...
A highly complex medical device like the Amniobed requires a very complex design control, quality management and risk assessment analysis to meet the toughest worldwide regulatory standards. We are excited and proud to be working with Greenligh Guru.
Those at Greenlight Guru are thought leaders when it come to quality management systems in the medical device industry. I have a high degree of confidence that as changes to the regulations occur, I won't have to worry about being out of compliance because we are using Greenlight Guru.
I highly recommend Greenlight Guru. They have taken a complex industry and made it into a product that is simple to use.
With Greenlight Guru, you've got software, but also what amounts to a personal consultant. Those connections are powerful.
We wanted a QMS solution that was robust enough to grow with us, but simple enough to get us started.