BOSTON, April 18, 2016 /PRNewswire/ -- TransPerfect Medical Device Solutions, the world's largest provider of language services and content management technology to the medical device industry, today announced the launch of the world's first "closed loop" digital labeling system, developed in concert with 121nexus under the EnCompass Partners Program.
121nexus is the creator of patented mobile technology that instantly connects medical device customers with online product information via bar code/UDI (unique device identifier) scanning technology. Combining 121nexus's technology with TransPerfect's EnCompass digital labeling ecosystem and patented process for labeling translation, this revolutionary e-labeling solution allows device makers to seamlessly share required regulatory/training information and marketing material with customers in any language.
Cuts Labeling Costs, Turnaround – Supports Compliance, Training, and Sales
The collaboration between TransPerfect and 121nexus marries cost-saving process automation technology with patented mobile scanning technology to achieve a long-anticipated industry objective: a system that satisfies evolving regulatory requirements for labeling traceability and risk management, while also delivering marketing and operational value.
Marc H. Miller, Division President of TransPerfect Medical Device Solutions explains, "The implementation of UDI technology has created an opportunity that the industry has been imagining since e-labeling was first proposed: a compliant, two-way system that ties physical products to digital labeling, training, and marketing material." To accomplish this feat, the companies have combined content and translation process automation from TransPerfect with mobile scanning (using existing barcode information) from 121nexus to link users to customized websites for product-specific information such as software updates, labeling and regulatory information, training materials, and marketing content.
UDI Provides Bridge to Evergreen Regulatory and Marketing Content
Industry insiders like Jay Crowley (27-year FDA veteran and Senior Adviser for UDI) have endorsed the effort. In a letter of support for the 121nexus approach, Crowley points to "the existence and need for solutions" that enable device manufactures to tie physical product to accurate online information.
The EnCompass partnership takes the initiative a step further by using UDI information to create a bridge between all types of device content and in-the-field products themselves. Explains Charlie Kim, CEO of 121nexus, "We have developed the only universal scanning app that reads GS-1, HIBCC, and ICCBA codes." The app pulls information from FDA's GUDID and manufacturers' digital content resources to "close the loop" for labeling information. Says Kim, "This provides the basis for the real-time post-market surveillance information that FDA is looking for."
Adds Miller, "The connection between the physical product and the evergreen online content is what enables device makers to push marketing content or generate revenue from training content." Utilizing labeling and product content to support marketing and operational efficiencies has been a long-held objective of the medical device industry. The partnership between TransPerfect and 121nexus delivers on this promise.
About TransPerfect Medical Device Solutions
TransPerfect Medical Device Solutions is the specialized medical device division of TransPerfect. With annual revenues of more than $500 million, TransPerfect is the world's largest provider of language services and content management technology to the medical device industry. From offices in more than 90 cities on six continents, TransPerfect offers a full range of services in 170+ languages to clients worldwide. With an unparalleled commitment to quality and client service, TransPerfect is fully ISO 9001 and EN 15038 certified across all offices. The Medical Device Solutions group is also certified to ISO 13485 and ISO 14971. For more information, please visit our website at: www.transperfect.com/meddev.
Headquartered in Cambridge, MA, 121nexus provides the simplest method to deploy item-level information securely while allowing real-time engagement. Global eIFU and UDI regulations for medical device labeling, combined with the growing use of mobile devices by medical professionals, has generated a demand for easy access to more relevant information. The solution is 121nexus e-labeling technology. 121nexus' patented technology gives medical device manufacturers the ability to share required information, issue recall updates, and push marketing information in any language with a simple scan of the existing packaging bar code. This best in class e-labeling technology goes beyond regulatory requirements to instantly deliver safety, training, and marketing information to medical professionals and patients around the world.
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SOURCE TransPerfect Medical Device Solutions