CGX is one of the world’s leading manufacturers of dry electrode EEG headsets that are designed for researchers in the fields of simulation training and virtual reality, among other things. About 18 months ago, CGX decided that their innovative headsets would also be well-suited for clinical use.
To get their devices approved for medical research, CGX moved to Qualio as their quality management software system (eQMS). The decision enabled them to get more devices to market faster with a system that scales alongside the company.
After surveying the market and demoing Greenlight Guru and MasterControl, the CGX team decided to implement Qualio as their eQMS. As a smaller, agile company, CGX didn’t need all the bells and whistles that ship with many QMS systems. They also didn’t want to be forced to use another company’s templates.
“We really needed a process we could make our own,” says Spencer Linton, CGX's General Manager. “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 has proven to be a shrewd one. Not only did Qualio make it easier for CGX to file their 510(k), it has also given them the flexibility early-stage companies need to pivot quickly while helping them improve collaboration with many different stakeholders across distributed environments. Qualio also helps ensure regulatory best practices while easily building a QMS that meets CGX’s unique needs.
Download the Case Study: CGX Uses Qualio to Deliver Innovative EEG Headsets to Medical Researchers