NEW SYSTEMS AND
3RD PARTY LABELING
The company in this case study is a multinational medical
device manufacturer, specializing in surgical care.
Their challenge was twofold:
• Ensuring their labeling solution integrated seamlessly with a
new ERP (SAP) and Quality system.
• Maintaining design and content control while extending print
functionality to a 3rd party contract manufacturer.
They needed to accomplish this while adhering to all Medical
Device Regulations (MDR) and complying with the FDA’s Unique
Device Identifier (UDI) regulations for labeling.