Case Study: Zebra Medical Technologies achieves a successful first quality audit and streamlined QMS with Greenlight Guru

How a New Breed of Medical Device Companies Is Leveraging Technology To Get More Done With Less Resources

Zebra Medical Technologies, a Silicon Valley startup spun out of Stanford, is developing a novel, non‑invasive imaging system to enable live cellular pathology (initially targeting skin cancer). With a three‑person core team and limited funding, Zebra needed a robust quality management system to support clinical development, regulatory readiness and an upcoming audit without hiring a full‑time quality resource or costly consultants, so they adopted Greenlight Guru’s medical device QMS/MDQMS.

Greenlight Guru delivered an industry‑specific QMS platform that Zebra used to manage both research and clinical products, organize documentation, and prepare for regulatory review. As a result, Zebra passed a California Food and Drug Branch audit “with flying colors,” avoided external consultants, saved significant staff hours, and accelerated readiness for an FDA pre‑submission and clinical prototype work—benefits Zebra says have already paid for Greenlight Guru.

Zebra Medical Technologies

Kate Montgomery

Lead R&D Scientist