CGX boosts product output by 140% with Qualio
CGX is one of the world’s leading manufacturers of dry electrode EEG headsets, designed for researchers in the fields of simulation training and virtual reality.
In 2020, CGX determined that their innovative headsets could also serve a vital clinical function.
To get their devices approved for medical research, CGX moved to Qualio as their quality management software system (eQMS). The decision has enabled them to get more devices to market faster with a robust system that scales alongside the company.
For five years, CGX sold its products exclusively to researchers at universities.
Expansion into the medical market opened a new range of customers, but also meant the business would have to adhere to a whole new slate of quality and compliance requirements.
CGX had been using an offline QMS that, in the words of VP Spencer Linton, 'got the job done'.
But operational ceilings meant the system was unscalable and couldn't keep pace with CGX's expansion plans. The system, for example, didn’t support working from home during the COVID-19 pandemic.
Seeking a better way forward, the CGX team began looking for an eQMS.
You had to be logged into our server to pull an Excel sheet. It quickly became a mess.
We wanted a flexible QMS system to develop products for a range of markets. It also had to be scalable as we grow our projects, personnel and sales.
We needed software to meet the needs of a 510(k) filing and satisfy the FDA's expectations for a well-documented design and development process.
After surveying the market and demoing Greenlight Guru and MasterControl, the CGX team decided to implement Qualio as their eQMS of choice.
As an agile start-up with big plans, CGX didn’t want to pay for superfluous software functionality, or be stifled into an overly templated quality approach.
We really needed a process we could make our own.
Qualio is flexible, it’s a great price compared to the competitors out there, and we can put all of our company inside the system.
The decision to move to Qualio was vindicated in weeks.
Not only did Qualio simplify CGX's FDA 510(k) process, it has unlocked the flexibility CGX needed to pivot quickly, helping them improve collaboration with multiple stakeholders across distributed environments.
Qualio also helps Spencer and his team to make regulatory best practice natural and automatic.
Qualio delivered a number of key benefits to CGX, including:
1. Easy onboarding and easy validation
Spencer oversaw a rapid validation process which wrapped up in less than three hours — something he credits to Qualio’s robust documentation.
And since CGX weren't migrating existing documentation into Qualio, onboarding was completed in record time too.
15 members of the CGX now actively use Qualio, including the quality team, engineers, contractors, and the company president.
2. Improved collaboration
CGX uses Qualio as a central hub to store all of their processes, SOPs and step-by-step how-to guides. As a result, all stakeholders — including contractors and consultants working remotely — can hop into Qualio and access information in a couple of clicks.
Qualio has therefore become a trusted, reliable single source of quality that enables CGX to move work forward faster.
3. Scalability and increased output
During the first three years of the company, CGX released 10 products to market. In the 18 months of using Qualio, they’ve released 12 products and revisions.
This 140% boost in product output, driven by sharper digital quality processes in Qualio, has lifted the lid on CGX's expansion plans and made the organization more profitable than ever.
Qualio helped us quickly build a system that was compliant for the medical device market.
We run all processes across our entire company through Qualio. It’s allowed us to reach beyond design and development.
Having that flexibility has really allowed us to find our best self as a company. Our output has gone through the roof.
