UL’S COMPLETE SERVICE OFFERING HELPS MANUFACTURERS ACHIEVE COMPLIANCE
On September 24, 2013, the U.S. FDA published a final rule requiring medical devices to have a Unique Device Identifier. Applicable products must comply with the tiered implementation deadline, established by device classification. This requirement extends to device manufacturers selling and marketing products in the U.S., including manufacturers exporting to the U.S.
Complete service offering approach available
UL understands the impact of UDI on your company’s systems and provides a comprehensive solution to support UDI from beginning to end. There are three interrelated elements to successfully implement UDI: Labeling, Informatics and Integration into your Processes and Procedures. Planning ahead allows you to identify internal resources, collect the appropriate data and make informed proactive decisions to ensure that your firm is fully prepared to meet these timely requirements. UL can help your organization meet the challenge of UDI compliance with our advisory and support services.
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