TransPerfect Medical Device Solutions, the world’s largest supplier of language services and content management technology to the medical device industry, today announced that Division President Marc Miller will address the MedTech Summit conference—the industry’s largest-ever MDR and IVDR event—in Brussels, June 17–21. The TransPerfect presentation “Using Automation to Meet Increased PMS and Other MDR Content Requirements” is scheduled for Wednesday, June 19, at 2:20 PM. For more information or to schedule an at-conference meeting, visit TransPerfect’s dedicated MDR and IVDR website.
About TransPerfect Medical Device Solutions
TransPerfect Medical Device Solutions is the specialized medical device division of TransPerfect, supporting over $30 million of active MDR and IVDR readiness initiatives. With annual revenues of more than $705 million in 2018, TransPerfect is 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, ISO 17100, and ISO 18587 certified. The Medical Device Solutions division is further certified to ISO 13485 and ISO 14971.
MDR and IVDR Drive Process Automation
According to previously published research from TransPerfect and regulatory consulting agency Qserve, “the MDR and IVDR are expected to increase both the volume and velocity of device-related content while also increasing the amount of regulatory scrutiny applied.” This “rising tide of content” is causing concern in key areas of regulated operations, such as post-market vigilance and reporting, labeling, and clinical data requirements.
“In the face of increased regulatory requirements, manufacturers must automate to keep pace; manual processes and unstructured content are not really an option after MDR and IVDR,” observed Miller.
EnCompass the Solution
Fortunately for manufacturers, automation technology exists that can reduce the costs, risk, and turnaround of regulated content, including PMS, labeling, and clinical data. TransPerfect Medical Device Solutions offers an array of these technologies and services as standalone modules or integrated into its custom-engineered EnCompass solution for MDR and IVDR content. EnCompass is a modular solution that includes XML single-source content management, translation process automation (including advanced AI), and automated publishing.
In addition to content, translation, and publishing automation, TransPerfect clients have access to other specialized services and technologies to support effective MDR and IVDR compliance:
- eTMF and clinical technology solutions
- PMS and vigilance reporting solutions
- E-learning development, localization, and testing
- Software localization tools, testing, and consulting
- Automated website localization solutions
- Patent, litigation, and contract support
- Multilingual digital media solutions
Miller concluded, “Between our in-depth industry experience and breadth of solutions, we are uniquely equipped to keep our clients MDR and IVDR compliant.”