Case Study: CGX achieves faster 510(k) filing and increased product output with Qualio

CGX Uses Qualio to Deliver Innovative EEG Headsets to Medical Researchers

CGX, a leading maker of dry electrode EEG headsets for research, decided to enter the medical market and needed a scalable, compliant quality management system to meet new regulatory requirements. Their existing offline QMS created roadblocks for remote work and slowed development, so CGX adopted Qualio’s eQMS to build a medical-device-ready quality system that could grow with the company.

Qualio delivered a flexible, easy-to-use eQMS that CGX could tailor to its processes, with simple onboarding, a 2–3 hour validation, and a central hub for SOPs that improved collaboration across 15 users and remote contractors. Using Qualio, CGX secured support for a 510(k) submission, accelerated time-to-market and scalability, and boosted output—releasing 12 products and revisions in 18 months versus about 10 products in the company’s first three years.

CGX

Spencer Linton

CGX's General Manager