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
Simplified EU MDR, FDA UDI, FDA 21 CFR 820 compliance
Elimination of inconsistencies through providing a single source for all printed and electronic labeling
Simplified engagement with Contract Manufacturing Organizations (CMOs)
Accelerated and de-risked Mergers and Acquisitions activity
Complete transparency across the medical device supply chain
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.
Testimonials
Discover how brands are using Kallik to transform and enhance their packaging, labeling and artwork processes.
The results were obvious and very clear to us. We can now achieve global artwork consistency across all our brands. This extends to multiple packaging formats and complex Information for Use leaflets.
Making global artwork changes such as logo or address updates could not be easier using Kallik’s ‘Where Used’ function. We were able to identify 10,000 affected artworks within seconds, with subsequent updates being underpinned by structured workflows and robust audit trails.
Kallik offered us a scalable global solution capable of adapting to ever changing business requirements. We wanted to empower those responsible for the data to enter it directly into the solution. This has enabled the business to drive ownership and accountability into the process.
Kallik has helped us to make our whole product launch process leaner. Compared to our previous way of working, Kallik's Automated Artwork Generator has saved our organisation over €100,000 a year.
Kallik enabled us to come from a process that was impossible to measure to a process we could measure. This benefit of transparency enabled us to focus and address inefficiencies in areas of the business that were true bottlenecks.
Our Customers
