Case Study: Global Medical Device Manufacturer achieves high-speed, FDA-compliant, fully traceable automated production with 42Q

Cloud MES Supports Sophisticated Automation in a High Speed, Highly-Regulated Manufacturing Environment

Global Medical Device Manufacturer, already using 42Q as their MES for Class II products, faced a move to high-volume Class III production that required fully automated, 24/7 lines with plans for 10 million devices per year. The new process handled miniature components with tolerances as tight as 10 µm and placement accuracy of ±0.4 mm, had stringent ISO 13485/FDA traceability requirements, clean-room staffing limits, and needed backflush integration with an Oracle inventory system — all with minimal factory downtime.

42Q’s cloud-based MES was implemented to integrate vision systems, in-line robots and test equipment across more than 50 processes, recording pass/fail results, date codes, serial numbers, voltage and functional-test data tied to unique part identifiers (including loading up to five date codes). 42Q delivered complete forward-and-backward traceability, Oracle backflush automation, throughput well beyond industry benchmarks, and near‑zero human intervention apart from feeder loading and maintenance, enabling regulatory compliance and actionable operational insight.