Case Study: Zyris achieves smoother EU MDR compliance and QMS control with Greenlight Guru

Zyris passes a week-long surprise audit with Greenlight Guru

Zyris Inc., a dental medical device manufacturer, faced significant challenges adapting to the new European Union Medical Device Regulations (EU MDR) while managing global growth. Their existing electronic quality management system (eQMS) was inadequate, creating obstacles for documentation, regulatory pivots, and efficient scaling. They sought a true partner in regulatory compliance and selected Greenlight Guru’s Medical Device Success Platform as their dedicated QMS solution.

Implementing Greenlight Guru’s modular platform allowed Zyris to control their transition, turning on specific modules like internal audit and CAPA systematically to manage EU MDR requirements. The solution provided an integrated, single source of truth for design controls, documentation, and quality processes. This partnership enabled Zyris to successfully navigate multiple notified body audits and a surprise audit from Health Canada, maintaining organization and document control. Greenlight Guru empowered Zyris to view quality as a integrated part of their identity, supporting continuous improvement and secure growth.

Zyris