The FDA’s new UDI labelling requirement will challenge device manufacturers to re-design their labelling process and product labels
One solution will make it easy to comply with the FDA’s UDI label content, design, GUDID upload and print regulations as well as with your own internal Colour-coding and branding requirements: Innovatum’s ROBAR software and QuickLabel’s Kiaro! on-demand inkjet label printer. Together we offer a validated FDA-compliance solution for printing UDI labels in Colour from blank stock!
Innovatum’s ROBAR labelling software and QuickLabel’s Kiaro! inkjet label printer work together to create labels that are accurate, cost-efficient, clear, and in-line with UDI labelling regulations.
Design Here, Print Anywhere in the World
ROBAR software allows you to design at your computer and easily print to Kiaro! inkjet label printers located anywhere in the -world through simple browser access.
UDI Compliance Today
ROBAR empowers you to access a single source of truth for labelling information whether your information is centralized or distributed. Innovatum’s ROBAR software uses a database that manages your content for fast, reliable and repeatable access to give you centralized, secure and auditable control over labels and content.
ROBAR allows you to centrally control and manage labels. You can design and test a label at one plant and then print an entire batch of the same labels at another. 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
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.
Line of Sight Supervision
Printing Colour 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 authorized administrators can 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. Plus, 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 Colour codes, barcodes, label sizes and materials. Instead 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 print newly approved label changes, you’ll increase line-of-sight supervision and you’ll have zero labels on hand to be purged from stock.
Colour Labels in 1200 dpi
The Kiaro! inkjet label printer creates gorgeous, accurate labels in spectacular 1200 dpi to allow you produce an easy-to-identify Colour code system. You’ll be able to more easily distinguish product variations with Colour code cues, identify the correct device in hospital settings for doctors and salespeople. You’ll reduce risk of costly errors due to selection errors at point of use, and save time in logistics with faster identification by warehouse staff.
With the photo-quality image capability of the Kiaro! you can accurately represent medical devices within your packaging. The Kiaro! will enhance logo branding on packaging, and create consistent quality and readability on all label sizes, including small label areas and wraparound label panels.
Medical Devices are shipped around the globe, and 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.
We’ll Come to You
The best way to find how a Kiaro! and ROBAR can improve your labelling process for UDI compliance is to see for yourself. Schedule a live demonstration, and we’ll come to your office to show you our printer and software. Contact us today to find out more!