Case Study: Zalgen Labs achieves a scalable, compliant paperless eQMS and 90% document digitization with Qualio

'Firing on all cylinders' and saving lives with a medical device eQMS

Zalgen Labs, a diagnostics manufacturer for diseases such as Lassa, Ebola and SARS‑CoV‑2, spun out in 2016 with a tiny team supporting ~30 medical products and quickly found its parent company’s paper-based QMS unsustainable. Facing FDA 21 CFR 820, ISO 13485 and EU IVDD requirements, Zalgen selected Qualio’s electronic quality management system (with Qualio+ migration support and Qualio Design Controls) to replace the legacy, manual processes that were consuming Director of Diagnostics Development Matt Boisen’s time.

Qualio digitized and centralized Zalgen’s quality system—migrating 100+ legacy documents and now managing more than 90% of company documentation—creating one scalable system for long‑term ISO, FDA and EU compliance. The Qualio solution (including training and Design Controls) automated workflows, reduced manual overhead so Matt no longer spends four‑fifths of his time on quality, mitigated immediate headcount needs, improved traceable training, and positioned Zalgen Labs for CE marking and 510(k) readiness.

Zalgen Labs

Matt Boisen

Director of Diagnostics Development