实例探究 > CGX uses Qualio to deliver innovative EEG headsets to medical researchers

CGX uses Qualio to deliver innovative EEG headsets to medical researchers

公司规模

SME

地区

America

国家

United States

产品

Qualio
Greenlight Guru
MasterControl

技术栈

eQMS

实施规模

Enterprise-wide Deployment

影响指标

Productivity Improvements
Customer Satisfaction
Innovation Output

技术

功能应用 - 企业资源规划系统 (ERP)
应用基础设施与中间件 - 数据交换与集成

适用功能

质量保证
产品研发

用例

监管合规监控
远程协作

服务

系统集成
培训

关于客户

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 has enabled them to get more devices to market faster with a robust system that scales alongside the company.

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挑战

For five years, CGX had been selling its products to researchers at universities exclusively. The company then decided to also start selling its products into the medical market, which meant they would have to adhere to a whole new slate of requirements. CGX had been using an offline QMS that 'got the job done.' But it wasn’t something the young company thought could grow alongside it. The system, for example, didn’t support working from home. 'It was creating a lot of roadblocks for us and slowing down development,' Linton says. Seeking a better way forward, the CGX team began looking for an eQMS.

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解决方案

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. 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.

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运营影响

Easy onboarding and easy validation: Onboarding was incredibly easy because the platform was self-explanatory and CGX didn’t migrate anything to Qualio. Today, there are 15 users on Qualio, including the quality team, engineers, contractors, and the president of CGX. Nobody’s had any trouble figuring out how to be productive on the platform. Linton also oversaw the validation process, which he wrapped up in two or three hours — something he credits to Qualio’s robust documentation.
Improved collaboration: Before Qualio, CGX was using an offline Excel-based QMS for a very brief period. It wasn’t a match for the company because they’re a small team that works with many different vendors. Now, CGX uses Qualio as a central hub where they 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 figure out how to do something right away. Simply put, Qualio has become a trusted, reliable system that enables CGX to move work forward faster.
Customer support and responsiveness: Linton says that whenever he’s needed help — not often — and whenever he has any ideas for new features, the Qualio team always quickly provides top-notch support and incorporates feedback rapidly.
Scalability and increased output: During the first three years of the company, CGX released about 10 products. In 18 months with Qualio, they’ve released 12 products and revisions. With Qualio, CGX has a reliable eQMS that can keep pace with their speed and can be adjusted to meet their specific requirements—whatever they might be tomorrow, five years from now, or even further into the future.

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数量效益