Case Study: 30 Technology achieves faster ISO 13485 compliance with Qualio

30 Technology achieves ISO 13485 in 6 months with Qualio

30 Technology, a UK-based developer of therapeutic nitric oxide products, faced a complex regulatory challenge with its paper-based quality management system. The manual processes were time-consuming and complicated compliance for its medical device and pharmaceutical products. Head of Quality & GxP Compliance Karen Hue led the search for an electronic quality management system (eQMS) and selected Qualio.

Qualio implemented its eQMS software, which was rapidly validated and put into use. The solution delivered dramatic operational results, enabling 30 Technology to achieve ISO 13485 certification within just six months. The Qualio system cut hours of admin time, saved the equivalent of three full-time salaries, and provided a fivefold return on investment.

30 Technology