Case Study: ViQi achieves an FDA‑ready eQMS in 12 weeks with Qualio (software + Qualio+ support)

A shiny new digital quality platform twinned with expert help

ViQi, a Californian start-up spun out of UC Santa Barbara, develops cloud-based AI/ML image analysis software used by life‑science organizations and as a medical device data system (MDDS). Facing FDA 21 CFR 820 regulatory requirements but with no internal quality expertise, ViQi needed a modern, digital eQMS and hands‑on regulatory support; they chose Qualio (including Qualio+ onboarding) to manage documents, training, and suppliers.

Qualio provided its eQMS platform plus expert Qualio+ guidance (including support from Sumatha Kondabolu), helping ViQi build a fully operational QMS in 12 weeks and register with the FDA in December 2022. Measurable results include 35 new quality documents, digital training with FDA‑compliant e‑signatures, supplier management with a risk matrix, and an avoided $20,000 consultancy spend—giving ViQi the processes and confidence to scale in the life‑science market.

ViQi

Dmitry Fedorov

Chief Technology Officer