Kallik delivers speed to market, compliance and change management for complex product labeling and artwork portfolios that significantly challenge medical device organizations today. Whether driven by localized market requirements, merger and acquisition or the launch of a new product, our software can ensure that your organization completes artwork and labeling projects with speed and compliance.
Simplified EU MDR & IVDR, FDA UDI, FDA 21 CFR 820, FDA 21 CFR Part 11 and EU GMP Annex 11 compliance
Elimination of inconsistencies, with a single source for all printed and electronic labeling
Easy integration with other enterprise systems such as PLM and ERP
Support business expansion with quick and easy onboarding of new manufacturing sites via Amazon Web Services (AWS) cloud
Complete traceability and transparency across the medical device supply chain with detailed audit trails of all activity
Reduce the risk of human errors, ensure compliance and increase efficiency with automated artwork and rules-based decision making
How Kallik Can Help Medical Device Organizations
Kallik has a wealth of experience in the medical device industry and we work with many well known global medical device manufacturers. Our software, Veraciti™, continually evolves to meet the changing needs of the industry. We work collaboratively with our customers to cater to their needs and help them to achieve their goals.
Kallik is the only labeling and artwork management software provider who offers a true end-to-end enterprise solution, from asset management through to print. Find out more about our software, Veraciti™, here.
Regulatory requirements for the medical device industry are constantly changing and evolving. Find out how Kallik helps medical device companies to stay compliant with current and forthcoming regulations here:
Check out our latest Medical Device resources
Why New Medical Device Regulations Require More Than Ad-Hoc Manual Processes
This time around, products really do have to ‘do what they say on the tin’!