NEW YORK--(BUSINESS WIRE)--TransPerfect, the world’s largest language services provider and the largest provider of language services and process automation technology to the medical device industry, today announced the introduction of its new EnCompass Solution, specifically configured to help address the estimated $20 billion cost of MDR/IVDR compliance. Built on modular, validated technology, the EnCompass system helps medical device manufacturers reduce the cost, risk, and turnaround time for labeling and marketing content creation, translation, and publication by up to 50%, while satisfying key MDR/IVDR compliance requirements (including UDI). For more information, visit: www.transperfect.com/meddev.
MDR/IVDR Compliance Cost Estimated at $20 Billion
One year into the transition period for the new MDR/IVDR, manufacturers are just beginning to assess the operational challenges that compliance will require. This is especially true in the area of device content (IFUs, software UI, websites, e-learning, translations, clinical data, etc), where the effort to meet new MDR/IVDR requirements using traditional, manual processes is contributing to the estimated $20 billion cost of compliance.
According to Marc Miller, Division President of TransPerfect Medical Device Solutions, “The increased pace and volume of content due to MDR is prompting device makers to implement automation technology to keep up. For example, our clients are using EnCompass automation technologies to achieve a 10x increase in labeling productivity.”
Immediate System Payback
The EnCompass System is a modular solution that includes XML component content management technology, automated translation processing, and UDI-enabled digital publishing and master data management. Each component (XML, translation management, UDI-enabled technologies) can be employed individually or together to deliver maximum control and MDR/IVDR compliance, while minimizing risk.
Notes Miller, “Versus manual processes, our EnCompass System is a quantum leap forward. And because we’re converting manufacturers from highly manual to highly automated processes, system payback can be immediate.”
The system’s UDI-enabled technology has multiple uses, including direct-to-user digital labeling and master data management. One major device manufacturer successfully employed this technology to solve a $3 billion supply chain issue and position itself for EU UDI compliance.
About TransPerfect Medical Device Solutions
TransPerfect Medical Device Solutions is the specialized medical device division of TransPerfect, the world's largest provider of language services and process automation technology. 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 ISO 17100 certified across all offices. The Medical Device Solutions group is further certified to ISO 13485 and ISO 14971. For more information, please visit our website at: www.transperfect.com/meddev.