FDA UDI, EU MDR, FDA 21 CFR Part 11
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SIMPLIFYING THE PATH TO MEDICAL DEVICE REGULATION (EU MDR)
CHOSEN BY THESE CUSTOMERS...
EU MDR introduces additional information that needs to be included on labels, forcing organizations to design new label templates that make room for data not previously part of the labeling system.
Whether you’re producing medical devices within Europe or supplying to Europe, as a manufacturer or supplier, you will need to adhere to the new EU MDR.