Soom, a pioneer in utilizing barcode technology to bridge information gaps between data sources and physical products, announces today a solution that enables compliance with the electronic instructions for use (eIFU) requirements (from EU No. 207/2012) included in the European Union's upcoming Medical Device Regulation (MDR). The solution is the first to offer medical device manufacturers the option to develop a mobile scanning application that eliminates the search process and guards against user error. It's also the only solution that automatically delivers IFU in a user's preferred language, providing quicker access to this critical information.
The goal of MDR, which goes into effect May 26, 2020, is to increase medical device safety and effectiveness. Modernizing the delivery of IFU—from printed to digital—is one way the new regulations will accomplish this. For many manufacturers, complying with the eIFU requirements means redesigning existing business processes.
"Building a comprehensive eIFU system is a time-consuming and expensive task for medical device manufacturers," said Charlie Kim, Soom president and CEO. "At Soom, our patented platform makes eIFU compliance simple, cost-effective and futureproof. We also included first-to-market capabilities like mobile scanning and single-step language selection that go beyond compliance; these features bring to life the regulation's larger goal of improving patient engagement and safety."
The Soom eIFU solution integrates with manufacturers' product lifecycle management (PLM) and content management systems (CMS) to deliver the most recent and accurate instructions for use. This content is shared via public websites, mobile app and supported through 24-hour call centers and printed IFU fulfillment as mandated by the regulations.
Manufacturers who also opt to develop a mobile scanning application can either white label the Soom mobile app or embed the Soom software development kit (SDK) into an existing application.
"Our eIFU solution delivers on Soom's mission to use the power and efficiency of technology to improve patient safety and outcomes—for everyone," added Kim. "Like all that we do, this solution creates a great user experience and delivers the absolute most relevant information to the end user, all with a simple scan."
Medical device manufacturers that are interested in delivering eIFU to users from a mobile scan can learn more at www.Soom.com.