Case Study: SOLIUS achieves ISO 13485:2016 certification in weeks with Greenlight Guru eQMS

How Solius Replaced Paper With Eqms to Gain Iso 13485:2016 Certification in Weeks

SOLIUS, a small med‑tech company developing a novel Class II phototherapy device to stimulate vitamin D production, faced the classic startup challenge of meeting medical device quality and regulatory requirements with a tiny, inexperienced team and a paper‑based QMS. Needing a cloud‑based, secure, scalable and affordable solution with expert guidance, SOLIUS chose Greenlight Guru to replace their ad‑hoc processes and tackle ISO 13485:2016 certification.

Greenlight Guru implemented its eQMS platform along with onboarding, templates and customer success mentorship, enabling SOLIUS to migrate records, link design/risk matrices, and demonstrate full traceability during audit. Using Greenlight Guru, SOLIUS achieved ISO 13485:2016 certification with just two dedicated staff, reduced audit time (3 days vs. 3.5), cut audit preparation by at least a week, and could review design matrices and supporting documents in days.

SOLIUS

James Wu

Quality Engineer