VIA = Traceability - When lives depend on it.

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FDA UDI Mandate – In a Nutshell White Paper

The United States Food and Drug Administration issued a final rule regarding Unique Device Identification System (UDI) on September 24, 2013.  This rule requires medical device manufacturers to label product including a UDI as early as September 24, 2014.  The rule has various implications on regulations 21 CFR 801.3, 803.3, 806.2, 810.2, 814.3, 820.3, 821, […]

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Traceability Imperative White Paper

Traceability is imperative due to market conditions, regulatory requirements, and competitive pressures.  The risks of operating without Traceability are high, including market share erosion, competitive disadvantage, unchecked liability, brand damage, and lost profits.  Finally, deploying Traceability doesn’t have to be a monumental task.  Get started by understanding and defining internal lot control, add product identification […]

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Top 5 reasons MES implementations fail

5. Unclear expectations MESA International identifies over 20 operations and initiatives under the MES umbrella.  Without focused expectation setting, stakeholders in an MES implementation may develop their own views of which initiatives will be addressed, and which operations will be supported by the MES upon deployment.  As the implementations unfold, each stakeholder may pull the […]

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