Case Study: MediBeacon achieves zero-finding ISO 13485 recertification with Greenlight Guru

How a Class III Device Company Passed Their ISO 13485:2016 Re-Certification Audit with a Modern QMS and Industry Expertise

MediBeacon, a medical technology company developing a Class III combination product, needed a more flexible and organized QMS to manage design, documentation, and audit readiness. Its paper-based system was difficult to maintain and made it hard to build a strong DHF, DMR, and traceability matrix while preparing for FDA and ISO 13485 requirements.

MediBeacon implemented Greenlight Guru’s MedTech-specific eQMS, including support for Design Control and Risk Management, and transitioned from paper in less than 3 months with help from Greenlight Guru’s customer success team. The result was a successful ISO 13485:2016 recertification audit with zero findings, along with an estimated 20% time savings per year and faster time to value.

MediBeacon

Laura Vitale

VP of Quality