Case Study: Zyris, a dental device manufacturer, achieves streamlined QMS and EU MDR readiness with Greenlight Guru

How a Partnership With Greenlight Is Making This Dental Device Manufacturer Smile

Zyris, a Santa Barbara–based dental device manufacturer known for its Isolite systems, faced mounting regulatory complexity as it expanded into markets like the EU under the new EU MDR. Needing a partner-focused quality management solution rather than a one-size-fits-all tool, Zyris selected Greenlight Guru’s eQMS platform to rebuild and scale its quality management system.

Greenlight Guru deployed a modular, medical-device–focused QMS that consolidated critical processes and data into a single source and allowed Zyris to enable modules incrementally with an agile workflow. The implementation simplified control and documentation, strengthened post-market surveillance and complaint handling, and helped Zyris successfully navigate several Notified Body audits—including passing a week-long surprise remote audit from Health Canada.

Zyris

Morris Sherwood

Person Responsible for Regulatory Compliance/Regulatory Specialist