Case Study: HeartWare achieves faster, more efficient complaint management (54% improved closure; 62% fewer late reports) with QAD CEBOS EQMS

QAD QMS Streamlines the Complaint Management Process

HeartWare is a global medical device company that makes ventricular assist devices (VADs) to support patients with advanced heart failure. Because its HVAD System is a Class III, high‑risk device sold worldwide, HeartWare must meet strict FDA and international regulatory requirements; however, its prior complaint‑handling process was manual, siloed and error‑prone, making timely, auditable management of patient complaints difficult during frequent inspections.

HeartWare implemented a configured QAD CEBOS Enterprise Quality Management System (EQMS) to automate its 14‑step complaint workflow, integrate quality data with ERP, and train cross‑functional users. The result was faster, more visible complaint management and measurable gains: 62% fewer late report submissions, a 53% reduction in open complaints and a 54% improvement in complaint closure rate, yielding quicker reporting for audits and improved patient safety.

HeartWare

Maurice Plourde

Senior Director of IT