TransPerfect Announces EnCompass Rapid Prototyping Program for MDR, IVDR Content Compliance

TransPerfect Medical Device Solutions, the world’s largest provider of language services and process automation technology to the medical device industry, has announced the introduction of its new EnCompass Rapid Prototyping Program. Specifically designed to demonstrate the benefits of XML content management and process automation (including AI-Assist), the EnCompass Prototype Program provides manufacturers with a working model of MDR and IVDR content compliance and cost savings.
 
The Rapid Prototyping Program combines validated content management technology from Astoria Software, process automation technology from TransPerfect, critical conversion technology from Stilo and information development services from leading consultant Mekon.
 
Said Mekon CEO Julian Murfitt, “Our 25 years of expertise with information architecture and automated publishing provides an important benefit for device makers looking to address increased content requirements of MDR and IVDR.”
 
Added Stilo CEO Les Burnham, “Automated content conversion services are especially important as manufacturers migrate to XML-based systems to support the increased volumes and throughput associated with MDR and IVDR.”
 
A Cure for the MDR and IVDR Headache
With only 18 months left before full implementation, the European Union’s new MDR and IVDR are a source of stress and concern for global device makers. The new regulations span a number of operational areas and, according to industry consultant, Qserve, will increase both the volume and velocity of content that device makers must manage.
 
The EnCompass Rapid Prototyping Program provides a low-cost, low-risk approach for device makers to test the benefits of XML content management, automated publication, and translation process automation, (including AI processes) for critical device content: IFUs, software UI, websites, e-learning, clinical data, etc.
 
According to Marc Miller, Division President of TransPerfect Medical Device Solutions, “Faced with substantially increased content volumes due to MDR and IVDR, structured content and automation technologies are emerging as the key components for an effective compliance strategy.”
 
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 more than 170 languages to clients worldwide. With a 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.
 
Astoria Software is an award-winning solution for enterprise content management and a division of TransPerfect. Astoria delivers the most comprehensive on-demand solution for building, managing, and assembling DITA/XML content to satisfy documentation requirements in the software, hardware, medical device, and other discreet manufacturing sectors.