UDIs for Medical Devices: Lessons Learnt from Cook Medical
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The FDA Final Rule on UDIs for medical devices is expected to be published in early August. Recently, the EU Commission announced their intention to take an internationally harmonised approach and follow the FDA’s decision over here in Europe.
But what does this mean for the industry?
Since 1963, Cook Group companies have been among the leaders in developing healthcare devices. We asked 3 key members from the Cook Group about the impact Unique Device Identifiers (UDIs) are having on their roles, the challenging aspects of UDI implementation and also lessons learnt from the adoption of the GTIN System earlier this year for all products coming out of Cook.
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