An Integrated RFID and Vision-Based Closed-Loop Quality Control Architecture for Sterile Medical Device Assembly Lines: Industrial Implementation and Validation

Medical device manufacturing requires strict quality control, reliable traceability, and compliance with regulatory requirements. In many cases, inspection activities are still carried out manually and production information is recorded separately, which can result in inconsistent defect detection and limited visibility of manufacturing performance. This paper presents the development and industrial implementation of an integrated closed-loop quality control architecture for a sterile single-use medical device assembly line, addressing the lack of integration between inspection, traceability, and control systems in existing manufacturing approaches. In the proposed approach, we combine radio-frequency identification, machine vision inspection, programmable logic control, and centralized production monitoring. RFID tags store the status of each unit at individual stations so that defective products cannot proceed to downstream operations. Machine vision systems verify component presence, detect missing parts, and confirm color-specific assembly requirements during production. The architecture was tested through implementation on an assembly line and evaluated with comparative pilot studies against a traditional manual inspection process. The upgraded line achieved scrap cost reductions of 52.77% and 53.23% while also improving inspection consistency and production traceability. The results demonstrate that integrating machine vision inspection with RFID traceability can significantly improve quality control and manufacturing efficiency in regulated medical device production.