Case Study: Zalgen Labs strengthens quality management and accelerates device readiness with Qualio

Zalgen Labs saves lives with Qualio and digitizes 100+ documents

Zalgen Labs, a small diagnostic kit manufacturer, faced a significant challenge after spinning off from its parent company. With a team of fewer than ten people managing around thirty medical device products, their inherited complex and paper-based quality management system was overwhelming and unsustainable. They needed an agile electronic quality management system (eQMS) that could scale with their small team, and they chose to implement Qualio.

With Qualio's eQMS, Zalgen Labs digitized its stack of over 100 documents and established a paperless framework for managing quality. The solution delivered an immediate return on investment by mitigating the need for headcount expansion. Qualio also provided design controls that brought the company closer to its regulatory submission goals, positioning them for their next phase of growth.

Zalgen Labs