Quality Traceability System for a Medical Device Company

Medical devices are tightly regulated for quality traceability. The customer wanted end-to-end traceability across raw materials, production, inspection, distribution and after-sales.

The team used the product unique identifier as the backbone, added batch and serial number management, recorded key process steps, inspection results and release information, and linked them to distribution and after-sales data. The system supports recall drills and can quickly scope affected products.

After go-live the system passed regulatory inspection, recall preparation time fell from days to hours, and quality management became markedly more standardized.