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.
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.
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...
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 ...
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.
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 ...
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.
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'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...
A lot of times, if people don't understand quality systems, they think they just want to use paper becaue 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 customi...
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.
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.
Relying on a general purpose or paper-based QMS for your medical device quality system leaves you exposed to compliance complexities and regulatory roulette.
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.
Our Postmarket Quality Management Software provides visibility that decreases risk so you can advance the success of your medical devices.
By Evan Luxon, Centese (Greenlight Guru customer), Medical Product Outsourcing, June 24th, 2019.
As an early-stage medical device company, it may seem simpler to implement a paper-based QMS than to choose from the thousands of QMS software providers out there. Better yet, you're saving money by choosing the paper-based route, right? Wrong.
By David Deram, Forbes, June 13th, 2019.
Quality is manifested by the level of commitment that’s invested. Quality outcomes don’t happen by chance; they are carefully crafted to deliver a memorable experience to the end user. This mindset is at the core of Greenlight Guru and serves as the heartbeat of the company.
A free webinar on the newly codified regulatory requirements for post-market surveillance (PMS) under the new Medical Device Regulations (MDR) that goes into effect May 2020, and how manufacturers can take a proactive role in their approach.