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 combine ISO 13485, ISO 14971-certified, patented language services with validated process automation technologies to provide you with a higher order of translation and content management solution – with a special emphasis on meeting the new requirements of MDR and IVDR.

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 combine ISO 13485, ISO 14971-certified, patented language services with validated process automation technologies to provide you with a higher order of translation and content management solution – with a special emphasis on meeting the new requirements of MDR and IVDR.

MDR & IVDR Solutions

According to Ernst & Young's report, How the new EU Medical Device Regulation will disrupt and transform the industry:

"It is difficult to estimate, in an industry as diverse as medtech, what will be the total cost of compliance with the EU MDR. One rough estimate is that the total cost of compliance, industry-wide, will be between 3.5% and 5% of revenue" – in other words: $20 billion.

The cost and complexity of MDR & IVDR compliance is a challenge – you need a partner armed with the right tools and know-how to help you leverage regulatory requirements into competitive advantage.

MDR & IVDR Content Compliance
EnCompass System

EnCompass is a modular solution that combines XML content management and automated translation processing (including GlobalLink AITM and business intelligence reporting). EnCompass is built with open API’s and is easily integrated with downstream labeling and e-IFU systems.

MDR & IVDR Research and Information

 

The Patient Implant Card:
Your Questions Answered

With help from the regulatory experts at Qserve, and with the expertise of supporting over $30 million worth of MDR readiness initiatives, we have compiled answers to some of the most commonly asked questions.
 

Download

Recent research from industry consultant Qserve predicts a dramatic increase in volume and velocity of content due to new MDR & IVDR labeling, clinical, and marketing regulations.

TransPerfect combines patented language services with validated automation technologies for solutions designed to address the complex challenges of MDR & IVDR compliance.

Validated
Content Management
Process Automation

Structured
Content &
Automation

E-TMF
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.

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.

Translation Automation with GlobalLink AITM

In order to keep pace with the increased content requirements of MDR & IVDR, device makers are turning to automation technologies, such as AI. However, in a medical device context, this technology must be handled with care. That’s why TransPerfect is certified to ISO 18587 (application of AI in translation), has developed device-specific AI engines (trained with +25 years of high-quality translations), and supported by qualified linguistic QC staff.

Secure and 21 CFR Part 11 compliant, our flagship Trial Interactive platform is in use with over 2,000 ongoing studies. Our e-tmf 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