Case Study: Medical Device Company Achieves Global Label Compliance and Accuracy with NiceLabel LMS

Medical device company achieves global compliance while improving labeling accuracy and reducing costs

Medical Device Company, a global spine-industry medical device manufacturer, needed a way to produce multilingual, UDI-compliant labels from a non-Unicode SAP environment without making major changes to its highly regulated systems. The company also needed to streamline a slow, manual approval process, support FDA CFR 21 Part 11 compliance, and reduce labeling errors across multiple facilities. NiceLabel’s NiceLabel LMS was selected to address these challenges.

NiceLabel implemented a centralized, web-based label management solution integrated with SAP ERP and SAP ECM, including automated printing, label preview and approval from SAP, workflow controls, and pre-built UDI barcodes. This enabled the company to manage labels from a single source of truth, eliminate manual data duplication, and print directly from SAP in multiple languages. As a result, Medical Device Company reduced label templates by hundreds, saved hundreds of man-hours per year, lowered production downtime and IT maintenance costs, and significantly reduced mislabeling and the risk of recalls.