Case Study: Optovue achieves FDA-compliant UDI labeling and near-perfect inventory accuracy with RFgen Software

Optovue - Customer Case Study

Optovue, a Fremont-based global manufacturer of ophthalmic imaging equipment, faced an urgent FDA mandate to apply Unique Device Identifier (UDI) barcodes to its devices and packaging and needed a real-time mobile data collection system that integrated with its Oracle E-Business Suite ERP. Optovue selected RFgen Software and its RFgen Mobile Foundations for Oracle E-Business Suite to meet strict labeling, traceability, and ERP-integration requirements under tight regulatory deadlines.

RFgen Software implemented RFgen Mobile Foundations to provide real-time bi-directional Oracle integration, generate FDA-compliant UDI labels, enable mobile barcode scanning for cycle counts, automate pick lists for kitting, and speed PO receiving. As a result, Optovue achieved measurable improvements — inventory accuracy rose from 99% to “near perfect,” cycle counts and receiving became faster and more accurate, and the company maintained regulatory compliance and uninterrupted shipments.

Optovue

Dana Barth

Materials and Facilities Manager