Case Study: xCures Achieves Faster, Stress-Free Quality Management with Qualio

How xCures built a compliant, controlled eQMS for their 2022 plans

xCures, a medical device company, was struggling with a manual paper- and Dropbox-based quality management process that made document control, change management, training, and audit prep overly time-consuming. Teams had to download, edit, and re-upload files for every change, key updates were missed, and quality admin consumed nearly all of Ami Anderson’s time, leaving little room for operations work.

With Qualio’s eQMS for documents, training, and design controls, xCures digitized its quality system and added Qualio+ support to speed onboarding and compliance. The result was a much more streamlined operation: Qualio helped save an estimated $130K in employee and consultant costs, deliver 400% ROI, cut audit prep from 6 days to about half a day, reduce quality event resolution from roughly 6 months to 30–60 days, and shorten new device time-to-market from about 5 years to 2 years.

xCures

Mike Trudnak

Vice President of IT & Information Security