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.
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.”
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.
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