Labeling content & artwork management provider Kallik is offering an advanced labeling and packaging solution to help organisations in the medical devices sector meet a ‘perfect storm’ of compliance changes.
The news is significant, says Kallik, as much of the market is believed to be lagging in preparing for regulatory changes, including the US Food and Drug Administration’s imminent unique device identifier (UDI) product identification standard. To be included on product labels, UDI will make individual items easier to trace as they move through the supply chain and beyond. The FDA requires UDI compliance in the US by as soon as September 2014, with Europe to follow within the next two to three years, then China and the rest of the world.
It says that its solution has been shown to help firms get set for UDI – as well as improve internal systems, help customers meet their regulatory requirements and improve profitability at blue chip sector customers such as Colloplast, BSN, and many others.
Apart from UDI, Kallik says that 2014 is going to be dominated by pressure from buyers for higher quality at lower costs, increased M&A/consolidation activity, accompanied by more need for internationalised/global products and marketing solutions – all of which means an integrated approach to labeling and artwork management is critical.
Medical device manufacturers will benefit from a robust, transparent process in place to deal with these pressures, says Kallik.
Neil Gleghorn, chief executive officer of Kallik said: “Rather than thinking of UDI labeling as a challenge, think of it as an opportunity to improve all your labeling processes.
“By centralising and automating the way all forms of product packaging, labeling and customer documentation gets created, approved, delivered and managed, we are helping customers consistently deliver significant benefits of cost, time and risk reductions.
“It also increases visibility, ensures labeling accuracy – while also making it much easier and faster to make changes to labeling output as requirements change.”