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Unique Device Identification (UDI) Compliance

USDM Life Sciences is the industry leader in Unique Device Identification (UDI) regulatory compliance solutions and services for the medical device industry.

Our team of project managers and subject matter experts understand UDI compliance better than any other compliance organization. Our UDI team is led by Jay Crowley, who had primary responsibility for the development and implementation of the FDA’s UDI system.

USDM Life Sciences will help you assess, plan and execute the changes and enhancements necessary to meet UDI regulations. Our team of UDI experts will assess your products, the markets where they are sold and determine an implementation strategy for the changes that need to be made. USDM’s assessment methodology is extensive and includes the labels and packaging, the management of identification changes to each product, the changes to PLM, ERP, EPCIS and packaging systems, changes to printing, vision inspection and warehouse/inventory management systems and interfaces to the GUDID.

USDM experts ensure that all changes and enhancements are implemented under the governing GMP regulations, under change control and validated prior to release for production.

Blog

  • Accredited Issuing Agencies for UDI
    As of September 2014, there are three issuing agencies for UDI that have been accredited by the FDA. Issuing agencies operate a system for assignment…
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Testimonials

  • Clintrak - Jeffrey D. Coffin
    I have had the great pleasure to work with Bob for 5 years in his position of VP of Quality at Fisher Packaging Services while I acted as Director of Quality services at a sister…
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