Case Study: Cardiovascular Medical Device Manufacturer achieves automated, compliant enterprise QMS with AssurX

Moving from Paper Processes to an Automated Enterprise Quality and Compliance System

A leading Class III cardiovascular device manufacturer of ventricular assist devices was struggling to scale its quality and compliance systems after rapid growth (300 to 1,000+ employees) and expansion across multiple U.S. and European sites. Its processes relied on disparate electronic and paper records, manual task routing, and time-consuming validation, creating delays across CAPA, non‑conformance, inspection and complaint workflows—and presenting regulatory and patient‑safety risks if not streamlined.

The company implemented AssurX’s configurable, 21 CFR Part 11‑compliant enterprise QMS to automate CAPA, eCAR, NCR, receiving & inspection, complaint investigations, and eMDR reporting with seamless Salesforce and ERP integrations. Automated assignments, dashboards, electronic signatures and two‑click FDA submissions delivered real‑time visibility, reduced manual routing and meetings, and eliminated over 2,400 manual hours per year in NCR management while improving KPI tracking, audit trails and time to resolution.