"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, CEO
"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 industry."
Greg Sommer, CEO & Co-founder
"Using the Greenlight Guru system has enabled us to better implement our quality system across the company and accelerate our product development."
Linda Cox, SVP QA/RA
"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 GG has been a phenomenal resource and support for us. I never feel like I'm weeding through the quagmire of compliance alone, they are part of our team."
Ryan Shelton, CEO
"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 help you reach your goals. They are fantastic partners."
Kayla Rodriguez Graff, Co-founder & COO
"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 us significant time and dollars on regulatory and we know the savings will be exponential as we grow! Our product will be to market months faster and Greenlight Guru is a critical piece of our success."
Mike Fisher, Director of Product Development
"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 adopted. Greenlight Guru is a great foundation to build the quality system that your company needs."
Ronny Bracken, COO
"$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, Former CEO
"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!"
Joe Hage, Leader
"When it comes to quality management software for medical device companies, they are simply the best in the space."
Allan Katz, CEO & President
"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."
Michelle Zwernemann, Director of Product Development
"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 through that filing cabinet anymore."
Kate Montgomery, Lead R&D Scientist
"We're all excited to have everything organized and to always know what the correct, most up-to-date version is."
Sara Naab, Co-founder & Quality Director
"Greenlight Guru is exactly what startups need. A lean, mean, compliant system for ensuring quality while allowing them to move their product forward. The other quality system solutions that we looked at were way more complicated than what we needed. Greenlight Guru has helped us implement something that makes sense for now while being able to grow with us."
General Leung, PhD, MSc, Founder
"We couldn't be happier with the decision we made to work with Greenlight Guru. Everything from the sales process to the onboarding to the continued support has been great."
Sven Schreiber, Director of Operations
"We immediately saw the usefulness of the traceability matrix that was generated by the system. It was also far easier to access the relevant documents from this matrix than from our old system."
Evan Jones, Product Development Engineer
"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."
Matt Bellman PhD, Co-founder & CTO
"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."
Adnan Ashfaq, Director
"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."
Rian Wendling, Director of Regulatory Affairs
"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."
Jed Johnson PhD, CTO
"Greenlight Guru has been instrumental for us moving so quickly through our ISO 13485 certification and I would highly recommend it."
Schelte Post, Quality Manager
"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 session he noted as well that our choice of Greenlight Guru made the interviewing and documentation reviewing transparent and fast. I’m amazed we were able to use and implement the software so quickly."
Eric Griffith, Senior Product Development Engineer
"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."