Case Study: Multinational Medical Device Manufacturer achieves streamlined logistics, improved FDA compliance, and reduced label formats with BarTender

Medical device manufacturer works with BarTender® to streamline logistics, ensure compliance, and enhance security

Multinational Medical Device Manufacturer faced a patchwork of disparate, unsupported ERP and labeling systems after years of organic growth and M&A. As it consolidated onto Oracle E-Business Suite the company needed a Single Source of Truth for master data, compliance with the US FDA’s UDI regulations, and a way to reduce the number of unique label formats. To meet those needs it selected BarTender label design and printing software to standardize labeling across the organization.

BarTender was integrated with Oracle E-Business Suite so Oracle supplies master data and native printing processes pass XML to BarTender, which transforms the data into FDA‑compliant labels. The implementation included optimized templates, reusable components, version control, a fully redundant architecture, and support for legacy inputs to avoid production interruptions. A pilot completed within one week and the BarTender-driven system was rolled out to multiple data centers worldwide, dramatically reducing unique label formats, increasing labeling accuracy and regulatory compliance, and enabling secure handling of regulatory information across the ERP.