Case Study: Restech achieves 0 non-conformances and 100% audit readiness with Qualio

Lifting a weight from the quality team's shoulders by going paperless

Restech, a medical device company making minimally invasive gastroenterological products, was running a manual, paper-based quality management system that left document control slow, error-prone and labor-intensive. Tasked with finding an eQMS that balanced cost, ease of use, fast setup and strong support, Restech selected Qualio in 2022 to manage documents, training and events.

Qualio centralized Restech’s QMS, replacing paper folders and wet signatures with digital document control, configured workflows for CAPAs and deviations, and online training. As a result, document updates dropped from two weeks to about four hours (a ~95% reduction), each quality event close-out was shortened by roughly 10–14 days, 100% of staff now complete training on time, and Restech recorded 0 non-conformances in its ISO 13485 audit—freeing staff time for continuous improvement and prompting plans to roll Qualio out to additional sites.

Restech

Lowell Hoffman

Director of Quality Assurance