Case Study: PhotoniCare achieves faster time-to-market and streamlined FDA submissions with Greenlight Guru

PhotoniCare Adopts Medical Device QMS Software to Accelerate Time to Market

PhotoniCare, maker of the TomiScope diagnostic device for middle-ear infections, faced the common early-stage challenge of wearing many hats while relying on a paper-based quality system that slowed documentation and risked gaps in regulatory readiness. Seeking a cloud-based, purpose-built medical device QMS, PhotoniCare chose Greenlight Guru’s MDQMS software and expert support to replace manual processes and shore up in-house regulatory expertise.

Greenlight Guru implemented its MDQMS—providing a living Design History File, in-app design controls, integrated ISO 14971-aligned risk management, electronic document routing, and hands-on customer success guidance—which eliminated countless hours of manual DHF preparation, centralized design controls, and streamlined approvals. As a result, PhotoniCare accelerated development stages, improved readiness for a 510(k) submission and future FDA/ISO audits, and gained confidence that documentation is complete and easily presentable, helping speed their time to market.

PhotoniCare

Ryan Nolan

Co-Founder & VP Clinical Operations