Case Study: 30 Technology achieves ISO 13485 certification in 6 months and a 97% reduction in quality task time with Qualio

How 30 Technology found the perfect eQMS for faster, smarter quality management

30 Technology, a UK developer of therapeutic nitric oxide products navigating both medical device and pharmaceutical regulations, faced a complex dual-regulatory landscape and a largely remote workforce. A heavily paper-based QMS created time-consuming manual processes, poor version control and training challenges, so the company sought an electronic QMS and turned to Qualio to provide a scalable, easy-to-use eQMS for documents, training, events and design controls.

Qualio implemented a rapid validated eQMS (christened “Fort NOx”), going live mid-December with all users trained by January, and delivered measurable impact: ISO 13485 Stage 2 certification unlocked in 6 months, a 97% reduction in core quality task time (from half a day to five minutes), and an estimated saving of three FTE salaries. By centralizing documents, training records and processes in Qualio, 30 Technology gained audit-ready compliance, greater oversight and a faster route to market.

30 Technology

Karen Hue

Head of Quality & GxP Compliance