5 ongoing challenges for UDI
from Packaging Digest
Many of FDA’s Unique Device Identification requirements have already phased in. The labels and packages of Class III and Class II medical devices, for instance, must now bear a UDI. “But UDI is not over,” says Ardi Batmanghelidj, President and CEO of Innovatum, a software and regulatory consulting company specializing in life science labeling and Unique Device Identification (UDI) compliance. “In contrast, it is just beginning.
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