Case Study: Centese achieves FDA 510(k) clearance and replaces paper-based QMS with Greenlight Guru

Centese Ditches Paper-Based QMS and Achieves FDA 510(K) Clearancea

Centese, an early-stage medical device company developing the Thoraguard intelligent surgical drainage system, had reverted to a paper-based QMS that slowed collaboration, increased manual work, and risked delaying regulatory timelines. Seeking a nimble electronic solution to replace spreadsheets and paper, Centese chose Greenlight Guru’s eQMS platform to manage document control, design controls, and risk management.

Greenlight Guru implemented its integrated eQMS—providing advanced document management, streamlined approval workflows, revision control, and system-wide traceability—which allowed Centese to refocus on high-value work. As a result, Centese achieved FDA 510(k) clearance in November 2018, avoided hiring extra oversight for a paper system, reduced administrative burden, and is now conducting three U.S. post-market clinical studies while relying on Greenlight Guru as a trusted partner.

Centese

Evan Luxon

Chief Executive Officer & Co-Founder