Case Study: Proscia achieves MDSAP certification and global market access with Qualio

Proscia Uses Qualio to Bring High-Quality Medical Device Software to Pathologists around the World

Proscia, a software company founded in 2014 that develops pathology and cancer‑research solutions, moved into clinical diagnostics and needed a cost‑effective, rapidly deployable electronic quality management system (eQMS) to meet regulatory requirements for international sales. To achieve MDSAP/FDA/ISO compliance and support a shift from microscope workflows to digitized slide management, Proscia selected Qualio as their eQMS.

Qualio was implemented for document control, history tracking, search and tagging, and team onboarding, and is now used daily by more than 30 Proscia employees. Using Qualio enabled Proscia to prepare for and achieve MDSAP certification, maintain a single source of truth for training and records, and bring their CE‑marked Concentriq Dx to market—delivering measurable audit readiness, faster regulatory submissions, and scalable support as the company grows.

Proscia

Barbara Young

Senior Quality Manager