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Feedback from UDI’s first roll out

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The Pharma and Medical device industry is well informed on the changes being implemented for better device identification and issue tracking known as the UDI ruling. The first wave of requirements for Class III devices is now behind us  and Med Device Online sat down with Jay Crowley, VP and UDI Practice Lead at USDM […]

Second UDI Compliance deadline due in September

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In September of 2013 the Unique Device Identification (UDI)  Ruling was put into action responding to the demand for more clarity, understanding and an easier way to update medical devices.  Manufacturer’s have been implementing this ruling into their processes and come September 24, 2015 the second deadline will be put into action.  Non-class III implantable, […]

In the News: FDA announces UDI marking clarification

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There is a recent release on a UDI ruling regarding the direct marking of the medical device.  Device Manufacturers have been implementing data requirements anticipating this ruling and now have a clear understanding of possibly the most important piece; the physical marking on the medical device. One of the leading factors in the marking process […]

In the News: Public access to Global UDI Database

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The UDI ruling has been hailed as a landmark decision in the medical supply industry as it allows for better education to doctors and to patients on the devices and products that are utilized as well as the ability to provide updates and recalls on products. The FDA has announced that public access is now […]

Implementing proper barcoding for your UDI transition

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The UDI ruling and implementation process has been discussed in many forums. In our previous discussions we have covered certain dates and criteria that are required to meet the upcoming regulations but one thing that has not been discussed significantly is one of the most important pieces: the UDI bar code and the implementation process. […]