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Aligning for Growth:
The Evolution of
Medical Device Labeling

The introduction of Unique Device Identification (UDI) regulations signals a seismic shift in the labeling of medical devices. Over the past twenty years, the development of labeling solutions for the highly regulated devices sector has been a steady evolutionary process – but not everybody has taken the journey. While some companies have recognized the commercial benefits of introducing more scalable solutions – driven by data, not label outputs – others remain on the lower rungs of the evolutionary ladder. But the introduction of a common UDI mandate is a once-in-a-generation game-changer that gives medical device organizations no choice but to change. What’s more, it will also have significant downstream implications right across the supply chain.
The onset of UDI is genuinely seismic: it charts the move from evolution to revolution. But its introduction could also provide a powerful opportunity for companies to accelerate efficiency and productivity, and drive profitability. As the new FDA requirements finally take hold, the questions for global medical device organizations are clear: is your current labeling infrastructure aligned with the new UDI regulations? Moreover, is it aligned to your business objectives? It can be.

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