Medical Devices Solutions

TransPerfect Medical Device Solutions

TransPerfect Medical Device Solutions

When basic components come together to form higher functioning, more complex systems, this process is called "Emergence". The life sciences provide the most familiar examples of emergent systems, because living things are more than simply a collection of elements and compounds.

"The whole is greater than the sum of the parts"
~ Aristotle

 

Emergent also describes TransPerfect Medical Device Solutions— we offer language and content management solutions designed to meet the wide-ranging needs of today's device maker, from start-up to global enterprise. Our validated technologies, combined with ISO 13485, ISO 14971-certified systems and patented translation processes, provide you with a higher order of language and content management solutions.

 

Validated
Content Management
Process Automation
& Digital Publishing Technology

UDI-Enabled
Digital
Publishing

E-Clinical
Trials
Technology

Automated
Website
Localization

Validated
Audit & Review
Technology

Modular Design for Peace of Mind

Our EnCompass System is built on modular technology that is custom-configured to best meet your specific needs. The various components can be employed stand-alone to address a specific requirement or integrated for an end-to-end solution. Thanks to UDI-enabled, mobile scanning technology, the EnCompass System provides the tools and strategy to deliver critical digital content – at scale and in every target language – to drive global revenue and satisfy regulatory compliance. Watch this short video to learn more.

XML Content Management

By eliminating manual formatting processes with advanced XML content management technology from TransPerfect, companies like Medtronic have increased publishing productivity by 10x – other clients have seen reductions in cost and turnaround of over 40%.

Globalization Management System (including Translation Memory)

By centralizing translation activities through GlobalLink, our supplier agnostic, process automation platform, manufacturers can reduce cost and risk and generate advanced analytics for optimal process control.

UDI-Enabled Digital Publishing

Unique technology combines a free mobile scanning app with UDI-connected digital product information. Jay Crowley, former Senior Advisor for UDI at FDA has stated, "It's no exaggeration to say that systems like this are why UDI was created."

Secure and 21 CFR Part 11 compliant, our flagship Trial Interactive platform is in use with over 2,000 ongoing studies. Our e-clinical trials technology, available in over 20 languages, delivers key functionality, including eTMF, Investigator Portal & Database, and LMS Training Management.

With OneLink technology, you can say "no" to complex website localization issues. And your IT staff will say "thank you", because OneLink enables you to rapidly create and deploy country-specific, multilingual versions of your site with zero IT overhead.

Automate Website Translation

Let's face it: translation review can be painful. PDF markup and other manual processes can lead to significant quality risks, wasted time, and reviewer dissatisfaction. Now, unique technology from TransPerfect provides in-country resources with a cloud-based review platform that delivers key functionality:

  • Integrated access to vital linguistic assets (glossaries and translation memories)

  • Standard or Custom grading/scoring models

  • Combine with Project Director module for real-time cost and quality analytics

Program Design
Management
& Continual Improvement

For over a decade, acquisition and consolidation have been driving forces in the device industry – resulting in larger, and often more fragmented organizations. Centralized management of shared services (e.g. translation) provides significant quality and financial benefits. However, achieving these benefits is often a challenge for device makers due to their decentralized structure and widely different needs between divisions and functional areas.

TransPerfect Medical Device Solutions offers a modular set of quality system tools, industry best practices, and validated, vendor-agnostic technology to help manufacturers reap the benefits of process centralization and automation, including increased quality and cost effectiveness and decreased risk.

 

 

Our Partners

Effective solutions require a connection between different systems.
By working together, TransPerfect's EnCompass partners help medical device manufacturers build optimized content management systems.

PRISYM ID delivers turn-key label management solutions that have a fundamental impact on clients' manufacturing processes and distribution. PRISYM solutions have been deployed by the world's top medical device makers, meeting their need for compliant label management and printing solutions.

SoftwareCPR® is an expert consultancy in regulated software validation, risk management, and Part 11 compliance for medical device software and has provided internal training for regulators such as the US FDA, Taiwan FDA, and Health Canada. It has also led or participated in relevant national and international standards development. In addition to validation services, software auditing, planning, and risk analysis services are also provided.

121nexus is a technology company that connects products to people. By simply scanning a serialized barcode (such as UDI), an end user can access product-specific digital information, presented via unique mobile websites, with any mobile device. Geolocation and API connections allow these highly interactive websites to present in any target language and actively collect critical business analytics. Using the 121nexus Platform manufacturers leverage existing infrastructures to immediately create bidirectional client communications and relationships. 121nexus.com

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