Case Study: Tenacore passes ISO 13485:2016 audit with Greenlight Guru

Tenacore Passes ISO 13485:2016 Recertification Audit with the Help of Greenlight Guru’s Modern Platform

Tenacore, a U.S.-based medical device repair and service company, was managing its quality operations with a paper-based QMS that made audits, documentation, supplier management, and cross-team collaboration increasingly difficult as the business scaled. To replace that fragmented system, Tenacore chose Greenlight Guru’s easy-to-use eQMS platform built for medical devices.

With Greenlight Guru, Tenacore migrated its QMS off paper, connected key quality processes, and improved traceability across documents, change management, audits, CAPA, training, and more. The result was a successful ISO 13485:2016 recertification audit within 10 months of implementation, with zero major nonconformities, 2x efficiency gains, and reduced compliance risk.

Tenacore

Alfonso Canto

QA Manager