Jointly Promote FDA Compliant Color UDI Solution

QuickLabel Systems, a business unit of Astro-Med Inc., has announced a marketing agreement with Innovatum by which they will actively promote one another's products. At the heart of the new agreement is an understanding that Innovatum's ROBAR Enterprise Label Management System and QuickLabel's Kiaro! inkjet label printer combine to form a complete FDA-compliant color label printing solution.

Under the new partnership, QuickLabel Systems and Innovatum will jointly promote an FDA compliant color UDI label printing solution comprising QuickLabel's Kiaro! inkjet color label printer and Innovatum's ROBAR enterprise label printing software. Medical device manufacturers will benefit from this combined system, which reduces costs by providing validated, UDI-enabled labeling in color.  

The agreement comes as medical device manufacturers move to comply in advance of the new FDA UDI label regulation, which requires each product to bear a Unique Device Identification (UDI) label composed of:

• a device identifier that is specific to a device model;
• a production identifier which includes the current production information for that specific device, such as a lot or batch number; and
• the serial number and/or expiration date. Most manufacturers' labels also contain color codes and color graphics to differentiate product models and brands.

QuickLabel Systems is a leader in digital color label printers that print full color labels in short-run batches, on demand. Innovatum is a leader in FDA-compliant labeling software that enables medical device, pharmaceutical, and biotechnology manufacturers to comply with the all-important upcoming UDI and serialization labeling requirement.

"For almost a decade, Innovatum customers have been looking for a robust color label printer that retains color fidelity and is easy to run and affordable in terms of material and stock. I believe, finally, with the advent of the Kiaro!, QuickLabel has hit it out of the park. I expect the Kiaro! to be a really powerful tool in color label printing within the life sciences vertical," says Ardi Batmanghelidj, president of Innovatum.

"Not only is ROBAR labeling software an end-to-end label design, management, and printing solution, but it can accelerate a manufacturer's 'go-live' date by several months because its solution can be rapidly validated for adherence with regulations such as FDA 21 CFR Part 11. Pharmaceutical and medical device manufacturers will reduce costs and save time with our combined solution for printing UDI compliant labels in color," states Eric E. Pizzuti, vice president and general manager of QuickLabel Systems. "We've admired Innovatum's FDA-strength enterprise labeling solutions for some time and we're pleased to deepen our relationship with them."