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Medical Device

Whether driven by localized market requirements or the launch of a new product, Kallik delivers speed to market, compliance, and change management for complex SKU portfolios that significantly challenge medical device companies today

The Leader in Medical Device Labeling

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Simplified EU MDR, FDA UDI, FDA 21 CFR 820 compliance

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Elimination of inconsistencies through providing a single source for all printed and electronic labeling

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Simplified engagement with Contract Manufacturing Organizations (CMOs)

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Accelerated and de-risked Mergers and Acquisitions activity

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Complete transparency across the medical device supply chain

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Competitive advantage within existing territories and when entering new markets


Increasing regulation and enforcement around the world is driving medical device organizations to seek solutions to better manage product and package labeling and to reduce compliance risks. Global accountability and transparency are key. 

Knowing who is working on which project, when it is assigned and who approved the design of label assets and finished products, is essential.  We save our medical device customers millions of pounds in recalls every year.