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Medical Device Labelers

5 Unique Device Identification Challenges

Many of FDA’s Unique Device Identification requirements have already phased in. The labels and packages of Class III and Class II medical devices, for instance, must now bear a UDI. “But UDI is not over,” says Ardi Batmanghelidj, President and CEO of Innovatum, a software and regulatory consulting company specializing in life science labeling and […]

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What I Learned While Presenting in Front of the FDA About UDI Management

I was invited to speak at a UDI-centric conference a few weeks ago in which FDA made presentations and attended mine. Jay Crowley, Indira Konduri- (US FDA’s GUDID Program Manager) and representatives from GS1, ICCBBA and other organizations also presented. I was presenting on behalf of the AIM North America Healthcare Committee on the topic

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