Case Study: PhotoniCare achieves 510(k) clearance with Greenlight Guru QMS Software

PhotoniCare achieves 510(k) clearance with Greenlight Guru

PhotoniCare, an early-stage medical device company developing a diagnostic tool for ear infections, faced challenges with a paper-based quality system. This inefficient process was time-consuming and risked quality issues as the team juggled multiple roles. Seeking to maintain agility and improve internal efficiencies, they searched for a cloud-based, purpose-built solution, which led them to Greenlight Guru's QMS software.

By implementing Greenlight Guru's agile QMS software, PhotoniCare streamlined its documentation and design control processes. The solution provided in-app guidance from industry experts and enabled fully traceable electronic document routing. As a result, PhotoniCare achieved 510(k) clearance for its OtoSight device, accomplishing this faster than would have been possible with a paper-based system. The team from Greenlight Guru also provided essential customer support, helping PhotoniCare prepare a high-quality FDA submission and positioning them for success in future audits.

PhotoniCare