Moving to the Cloud can be an easy choice for regulated Life Science companies. USDM's Cloud VAP offers a subscription compliance model.
USDM Life Sciences is the industry leader in Unique Device Identification (UDI) regulatory compliance solutions and services for the medical device industry.
Our services and solutions are tailored to the UDI Final Rule in the United States and the UDI Regulation in the European Union (EU).
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.