Easy UDI Compliance with the Kiaro! and ROBAR
The FDA’s new UDI labelling requirements constantly challenge device manufacturers to re-design their labelling process and product labels. There has to be an easier way to update labels without sending out new print orders and laying labels to waste.
What Can They Do for You?
Both easily comply with the FDA’s UDI label content, design, GUDID upload and print regulations as well as your own internal color-coding and branding requirements. Together, they offer a FDA-compliance solution for printing UDI labels in color from blank stock!
Innovatum’s ROBAR labelling software and QuickLabel’s Kiaro! inkjet label printer collaborate to create labels that are accurate, cost-efficient, clear and in-line with UDI labeling regulations. You can design here and print anywhere. The ROBAR software also allows you to design at your computer and easily print to Kiaro! inkjet label printers located anywhere in the -world through simple browser access.
It even allows you to centrally control and manage labels. You’ll always know what, when and where each printer is printing, and how it’s functioning no matter where you are.
Security for Sensitive Data & Durability
The Kiaro! works with ROBAR’s Control Layer to protect all of your secure data entry with authenticated access. Granular Security prevents unauthorized access, controls workflow permissions, and manages printing permissions. With the Control Layer you can control quantities and reprints, limit operator data entry, and capture auditable information for your entire system.
Medical Devices are shipped around the globe; therefore the labels must maintain their readability, quality and scan-ability on a number of different media. The Kiaro! is capable of printing scratch and abrasion resistant labels that survive ETO sterilization, and can stand up to international shipping.
Line of Sight Supervision
Printing color labels with the Kiaro! on-site allows for immediate supervision to verify that labels are in-line with regulatory standards. You see labels as they’re printed to ensure there is no mislabeling, and allow authorized administrators to instantly revise labels to comply with new regulations or marketing demands.
Plus, you control label designs yourself, and don’t have to worry about handing responsibility to an outside print-house.
Cost Reduction with the Kiaro!
Having a Kiaro! label printer for UDI compliant labels onsite will dramatically reduce your costs. The Kiaro! eliminates the risk of using obsolete labels, eliminates the risk of choosing the wrong label from inventory, and completely eliminates excess label inventory.
The Kiaro! inkjet label printer creates gorgeous, accurate labels in spectacular 1200 dpi to allow you produce an easy-to-identify color code system. What’s more, with the Kiaro! the labeler is the operator – no more middlemen printing companies who increase the risk of non-conformance with FDA standards.
Short-Run Label Printing with the Kiaro!
With the Kiaro! you don’t need to worry about carrying thousands of pre-printed labels for every product variation, all with different color codes, barcodes, label sizes and materials. You print only the UDI specific labels you need, when you need them.
The Kiaro! transforms your organization into a just-in-time label producer that doesn’t waste labels, and never deals with unused or obsolete pre-printed inventories. With printing short-runs you can instantly produce newly approved label changes, increasing line-of-sight supervision and have zero labels to be purged from stock.
See for Yourself!
Schedule an in-person demonstration with a Kiaro! label printer. We’ll come to you and use your artwork to show you exactly how well our printers can create your labels. Learn more and contact us today!