Case Study: Centese achieves 510(k) clearance and streamlined quality processes with Greenlight Guru

Centese avoids hiring a half-time employee and achieves 510(k) clearance with Greenlight Guru

Centese, an early-stage medical device company, was burdened by an inefficient paper-based and Excel-driven quality management system (QMS). This manual approach consumed excessive time on administrative tasks, inhibited collaboration, and threatened to delay their 510(k) submission for their Thoraguard surgical drainage system. Seeking a nimble and purpose-built solution, they turned to Greenlight Guru for its medical device QMS software.

By implementing Greenlight Guru, Centese streamlined their design controls, risk management, and document approval processes with a system built for regulatory compliance. The solution eliminated the need to hire additional staff to manage quality and allowed the team to refocus on high-value product development work. As a result, Centese achieved 510(k) clearance efficiently and established a scalable QMS foundation for future market expansion, crediting Greenlight Guru as a key partner in their success.

Centese