A Unique Device Identifier (UDI) needs to be included on device packaging and labeling with device attributes being submitted to a new database (GUDID) facilitating device and manufacturer traceability. Following its success, similar initiatives are now rolling out globally, most notably the new EU MDRs. Kallik supports many major medical device manufacturers with their UDI labeling requirements.
How does Kallik help with UDI compliance?
Kallik helps medical device manufacturers ensure their products are correctly labeled in accordance with UDI requirements including human and machine-readable device and production identifiers along with the correct formatting of manufacturing and expiration dates.
• UDI compliant machine and human readable barcodes included as standard
• End-to-end system from artwork creation to factory printing, ensuring labels printed comply with the UDI standard
• Integration with production planning systems such as ERP to ensure traceability and connectivity, as well as auto population of run-time data
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’!
UDI & Product Traceability For Medical Devices: White Paper
How a more strategic approach to labeling digitalization can better serve businesses & regulators
Lessons & Leftover Challenges from MDR Preparations: What Next?
How medical device companies can effectively overcome the challenges posed by EU MDR
Reducing Errors In Factory Print: The Case For Labeling Digitalization
It is too risky to leave the accuracy of market-facing product information to chance
EU MDR Labeling Compliance - Are We There Yet?
Bob Tilling, VP Global Sales, explains how medical device manufacturers can recover lost time
How Companies Are Using New EU MDR Regulations To Improve Artwork & Labeling Processes
EU MDR forced changes on medical device manufacturers but has led to improvements in multiple areas
Is Your Medical Device Organization On Track To Comply With EU MDR?
The clock is ticking on the need to ensure compliance with the EU Medical Device Regulation (EU MDR)
EU MDR: An Opportunity For Medical Device Manufacturers
Compliance is not a short-term business overhead, it is an opportunity to improve best practice
What We Can Learn From EU Medical Device Regulation Compliance Preparations
MDR requirements alone should not determine how manufacturers overhaul their label management
Key EU MDR Changes You Need To Know About
New medical device regulations substantially change the ways manufacturers market devices in the EU
Why UDI Is Europe's Latest Hot Topic
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Why Your Business Should Act Now To Be Compliant With IVDR
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