Case Study: NanoDx achieves faster ECO cycles and simpler compliance with Arena Solutions' Arena QMS

Eliminating Backlogs and Compliance Hurdles With Cloud QMS

NanoDx™, Inc., a developer of point-of-care diagnostic solutions, struggled to manage quality documentation and engineering changes using paper, spreadsheets, and disconnected tools. As a startup working toward ISO 13485, FDA, and EU IVDR compliance, NanoDx needed a cloud-based QMS to reduce confusion, eliminate backlogs, and keep distributed teams aligned on the latest product revisions. Arena Solutions’ Arena QMS was selected to help address these challenges.

Arena Solutions implemented Arena QMS to centralize product and quality data, automate change management, and connect items, BOMs, drawings, and quality records in one system. The result was 10X faster ECO cycle times, stronger traceability, easier training record management, and simpler compliance with FDA and international regulations. NanoDx also reduced the time spent searching for information and processing engineering changes while improving collaboration and readiness for commercialization.

NanoDx

Angie Swanson

Lead Quality Engineer