New professional society journal article reviews the status, forecast, and putative safety benefits of UDI implementation.
NATICK, MA – April 1, 2008 – Clinivation, Inc. announced today the publication of a new professional society journal article coauthored by clinivation thought leaders in the areas of product safety, postmarket surveillance, risk management, and regulatory affairs.
The article entitled “Unique Device Identification: The New Era of Medical Device Safety” is published in the April, 2008 edition of the Regulatory Affairs Professional Society journal Regulatory Affairs Focus.
The article addresses unique device identification (UDI) related experiences in one-dimensional barcoding of drugs and biologics. It also reviews the milestones and forecast of U.S. Federal legislation and regulations, and the myriad putative benefits of UDI.
The article is coauthored by Richard Morroney, RAC, CQA, Vice President, Quality & Regulatory Solutions, clinivation, Inc. and Taras Bouzakine, RAC, CQPA, clinivation, Inc.
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