TransPerfect Medical Device Solutions offers a range of industry-leading processes and technologies designed to meet all of the content needs of today’s device maker, from
Two seasoned practitioners share their perspectives on XML and the benefits it holds for device makers. Guests include Marc Miller, Division President of TransPerfect Medical Device Solutions, and Steve Huffman, former Manager of Labeling Services for Medtronic’s Neuromodulation business, now also with TransPerfect.
Expert Opinion is a podcast by TransPerfect Medical Device
The content management costs for global device
Exclusive and recently published research from noted industry consultant, TforG.
Key highlights include:
Changes in content and channels have real implications for global device
Cut Costs and Manage Risk for All Your Clinical,
Marketing, and Labeling Content
Research indicates that every year, device makers worldwide miss out on $3 billion in content management
Modular Design for Peace of Mind
TransPerfect's solutions are different because they are risk-based and custom-designed for medical device makers. Separate modules from our GlobalLink suite can be employed individually or together to help meet your process needs. Whether you need flexible file submission and tracking with the GlobalLink Portal, in-country review and terminology management with GlobalLink Translation & Review Portal, system-wide metrics and automated translation memory processing with GlobalLink Project Director, or even automated XML publishing with Astoria Software or Vasont Systems—you can rest assured that TransPerfect will always handle your content with mature, validated technology and patented best practices.
The whole is greater than the sum of the parts
When basic components come together to form higher functioning, more complex systems, science calls this process “Emergence”. Biology provides the most familiar example of emergent systems, because life is so much more than simply a collection of elements and compounds.
“Emergent” also describes TransPerfect Medical Device Solutions—our validated technologies, along with our ISO 14971 certified, patented risk management processes, provide you with a higher order of language and content management solutions. And because our technologies and services are already in use with industry-leading manufacturers like Medtronic, Boston Scientific, Cook Medical, Gore Medical, Philips, St. Jude, and many more, you can have confidence that you are working with the most trusted solutions in the industry.
In addition to risk-based, patented services, TransPerfect Medical Device Solutions offers:
Specialized Language & Content Solutions
for Medical Device Makers
"...the staff has also been extremely capable and resourceful. We receive quick responses to inquiries, prompt attention to technical challenges and complete cooperation when process changes are needed. There is a real sense of partnership that the TransPerfect Medical Device Solutions staff brings to their work..."
We were the first translation service registered to ISO 13485 and the world’s first ISO 14971-registered company. Our risk management methods are Notified Body-endorsed and patented (U.S. Pat No 8,140,322) to provide you with quality peace of mind. By combining service best practices with validated process automation technology and worldwide resources, we build custom processes for our clients that decrease content cost, risk, and turnaround.
EnCompass System for Content Management and
"Originally, UDI was developed to cut through the complexity of the U.S. device distribution system and facilitate critical recalls. However, as implementation has progressed, it's become increasingly clear that UDI can and should serve a much larger role. The EnCompass system—including the 121nexus platform—is the first commercial product to deliver on this promise. It's no exaggeration to say that systems like this are why UDI was created."
According to Jay Crowley, former FDA Senior Advisor for UDI.
E-Learning Development and Localization Expertise for Medical Device Manufacturers
“In nearly three years you have never once missed a deadline, even delivering the most recent courses three weeks early... Thank you for your continued support and the amazing changes that have made the translation process faster and more affordable.”
Our process combines award-winning e-learning with 25 years of medical device expertise. TransPerfect’s e-learning development and localization services are in-use and delivering results for device sales, clinical, and compliance training.
Translation Audit & Review Services – Powered by Advanced Technology, Supported by Notified
“In combination with a linguistic QA check (such as your BackEdit process), your use of the SAE J2450 metric provides an objective methodology for inspection of translated material. It therefore provides an effective audit process for existing [legacy] translations.”
Whether you need to assess the quality of your existing translations or you want to get control of translation suppliers, a well-structured audit program can help. TransPerfect combines advanced technology with Notified Body-endorsed metrics and processes to provide you with an objective evaluation of your translated content.
Effective solutions often 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