Case Study: ViQi achieves FDA-ready quality management with Qualio

ViQi saves $20,000 and registers with the FDA using Qualio

ViQi, a small medical device data system startup from California, lacked internal quality expertise as it planned its entry into the highly regulated life science sector. Their challenge was to rapidly establish a proactive quality baseline and achieve FDA registration without the regulatory knowledge to create the necessary documentation and processes from scratch. They turned to Qualio for its eQMS platform and expert support.

With Qualio, ViQi received both a digital quality management system and direct guidance from a quality success team. This partnership enabled them to build their QMS, create all required documents and SOPs, and successfully register with the FDA within just three months. The solution saved them $20,000 in planned consultancy costs, made their quality journey possible, and provided a powerful talking point for new sales conversations.

ViQi