Is UDI a Big Problem for Medtech?

Friday, August 5, 2016

Source: Qmed

Only 15% of medical device industry professionals helping to implement FDA’s Unique Device Identification rule say their companies are ready for upcoming compliance deadlines, according to a report released this month by enterprise labeling services company Loftware (Portsmouth, NH) and professional services firm USDM Life Sciences (Santa Barbara, CA).

The two companies' poll involved 120 medtechprofessionals focused on regulatory, IT, and labeling. Most of them—93%—said theUDI requirements were noticeably impacting their company's labeling processes. Only half of them said the barcode labeling software used at their companies would be able to scale to meet long-term UDI requirements from FDA, as well and other requirements coming into play in markets outside the U.S. Nearly three-fourths said their companies were juggling between two and four barcode labeling software services. 

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