The new European Medical Devices Regulation (MDR) is forcing companies to review their labeling infrastructure as they battle for organisational preparedness The labeling of medical devices is already ...
With a September 24, 2022 compliance date looming, the U.S. Food and Drug Administration (FDA) announced that will delay enforcement of its requirement to submit Unique Device Identifier (UDI) data ...
On January 4, 2016, the Food and Drug Administration (FDA) released a draft guidance intended to clarify the Unique Device Identifier (UDI) labeling requirements for certain medical devices packaged ...
Under the FDA's newly enacted UDI rule, devices must be shipped with a unique identification label. (Click to expand.)--Courtesy of the FDA The FDA originally proposed requiring implantable medical ...
The safety and reliability of medical devices is paramount. However, there are times that issues arise, causing safety and other potential concerns. To quickly and efficiently handle these situations ...
Under the FDA's newly enacted UDI rule, devices must be shipped with a unique identification label. (Click to expand.)--Courtesy of the FDA "Mr. UDI" gave industry advice on complying with the complex ...
Want a sustainable, extendable UDI program? Here are five reasons why your medical device company needs to implement an Enterprise Labeling Solution. Compliance with the UDI rule requires a ...
Medical device makers are feeling the weight of the Food and Drug Administration’s unique device identifier regulations. Loftware and USDM Life Sciences conducted a nationwide survey that polled ...
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