The first article in this five-part series on addressing unique device identifier compliance provided an overview of unique device identification. We discussed the four core compliance requirements along with the anticipated benefits of regulation, from the primary objective of improved patient safety and care to the numerous business benefits to be gained by many in the medical devices industry. Then we identified data challenges likely to be faced by organizations required to comply and we introduced enterprise information management as a valuable approach for tackling those data challenges.
This article starts with a discussion of why EIM should be employed by organizations tasked with UDI compliance. We then dig deeper into an essential foundational element in any EIM program — data governance — and apply this discipline to the specific data challenges associated with compliance.
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