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.
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.
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.
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.
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.
Learn what content changes are coming under MDR for your Labeling, Marketing, and Post-Market Surveillance materials, as well as technology and process recommendations for what you can do about it...right now!
With 6 months until new EU medical device rules, what's the state of play?
Nov. 26, 2019
Implementation of sweeping new rules overhauling how medical devices are regulated in the European Union is just six months away. Industry has been arguing for more than a year that the system isn't yet ready to handle the onslaught of devices that must be reviewed under the Medical Device Regulation...
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.
TransPerfect combines patented language services with validated automation technologies for solutions designed to address the complex challenges of MDR & IVDR compliance.
(Click on a block to learn more about that service)
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.
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.
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
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.
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
For over 25 years, TransPerfect Medical Device Solutions has delivered the highest quality translated medical device labeling. Based on our ISO 14971-certified system, we hold the world's only patent for medical device labeling translation risk management (U.S. Pat No 8,140,322).
Key differentiators of our process include BackEdit™ and Linguistic Risk Management. BackEdit provides a vital check for semantic accuracy in translated labeling and mitigates the risk of Serious Errors (may cause patient harm) by up to 50% over standard translation processes. Linguistic Risk Management helps satisfy closed-loop QA, quality at the source, and other important QC objectives.
These differences pay off!
In an audit of over 1,000,000 words across 21 languages produced by other language service providers, TransPerfect's patented process was shown to be over four times more effective than the standard industry process at eliminating Serious Errors from medical device labeling.
In combination with validated content management and process automation software, TransPerfect's risk-based labeling translation processes can help ensure your lowest "cost of compliance" today, while future-proofing your labeling for MDR and IVDR compliance tomorrow.
It is widely acknowledged that medical device marketing material is among the most difficult type of content to translate. Not only does the translated content need to be technically accurate, it also must be fluent and persuasive in the target language. In addition, many treatment areas possess their own professional jargon or specific terminology which adds another barrier to achieving quality translation.
To overcome these challenges, TransPerfect supports clients in three key areas:
Our linguistic resources are tested according to nine (9) medical device subject areas and two (2) device content types... including Marketing Content. Only qualified medical device linguists with superior marks for translation style are considered.
The success of any marketing translation is significantly enhanced by input from the field. This is especially true in the case of medical device content. Distributor-reviewed glossaries, client-supplied samples for Style Guides, and formal Language Champion programs are all examples of best-practice approaches for effective input from the field.
Ongoing field input requires automation technology for audit, review, and reporting. Validated review tools can deliver seamless reviewer integration, shared access to linguistic assets (glossaries and translation memories) and, when combined with process automation technology, access to advanced, real-time analytics.
Occasionally, local markets (especially in Asia) may re-write materials to best suit local needs. In this case, it is advisable to produce a back-translation of the content as an important regulatory check. Our Translation & Review Portal provides validated technology that helps automate the review of translated marketing materials – for both in-country reviewers as well as into-English compliance verification.
Through our specialized Legal Solutions division, we offer a full range of Patent, Contract, and Litigation support services designed to help device makers protect valuable Intellectual Property (IP) and reduce the overhead of legal action around the world.
IP is the heart of the medical device industry; manufacturers need cost-effective international protection for this valuable asset. The TransPerfect process for filing international patents makes IP protection more affordable – our clients pay up to 50% less for translation and attorney fees and enjoy a significant reduction in administrative overhead and cost.
Commercial agreements, HR documents, and M&A materials are the day-to-day content of a global device manufacturer. We have the specialized legal services designed to ensure confidentiality and reduce the cost of legal activity. We also have the technology to facilitate easy review of translated content for comprehension and compliance.
Growing international operations expose device makers to increasing global liability. TransPerfect's Legal Solutions group helps device makers navigate complex litigation environments with forensics and e-discovery services, managed review and legal staffing services, and deposition and trial support services. Our global presence means we can provide local, in-country support for device makers worldwide.
Today's medical device maker supports global constituencies and workforces. Communications within the organization, as well as with shareholders and customers, must be fluent and accurate in every target language. TransPerfect has the specialized linguistic resources (Legal, Finance, Human Resources, and Corporate Communications) and diverse production capabilities to address every type and format of corporate messaging. From codes of conduct, to employee handbooks, to "Letters from the President" – even localized (translated) video presentations – TransPerfect has the depth and breadth of resources to support your corporate communications in every language.
Manufacturers across all industries (including medical device) are recognizing the benefits of video. According to HubSpot:
However, in order to realize these benefits for international markets, you must first localize (translate) your video or multimedia content.
Multimedia Localization: Video Translation, Subtitling, and Dubbing
TransPerfect delivers professionally produced, multilingual video and multimedia content for a variety of applications, including marketing, training, and patient information. Your project will benefit from our worldwide, in-house production facilities and staff, combined with ISO 13485, ISO 14971-certified translation processes. The result? Expertly produced video and accurately translated medical device content to support your global messaging. Our tested processes for subtitling and over-dubbing include:
First, we create and QC a timed transcript of your video content. For subtitles, our process includes timing-to-picture and character length definitions to ensure proper synch.
Our medical device linguists are tested in nine (9) medical device subject matters and two (2) content types to ensure technical translation accuracy. Device-related content is produced under our patented, ISO 13485, ISO 14971-certifed processes for additional linguistic peace of mind.
TransPerfect utilizes only native-language, professional voice talent at our in-house, worldwide production facilities. Bilingual Supervisors provide in-language direction and reduce the risk of re-recording and increased cost.
Using the latest post-production technology, our engineers edit, mix, and deliver content to your specific requirements – regardless of the application.
TransPerfect Medical Device Solutions provides you with comprehensive multimedia services that combine technical video expertise, in-house (worldwide) production resources, and patented, subject-specialized translation. Our turnkey solution guarantees that you benefit from tomorrow's localized digital media today!
Major device makers are leveraging UDI and the modular EnCompass system to meet critical business requirements and support UDI-enabled digital publishing:
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.
Medical device makers' websites contain product information (labeling), along with marketing and corporate content that must be fluent and technically accurate in each target language. TransPerfect Medical Device Solutions has the diverse resources and specialized processes to address this key requirement. However, the changing pace of business technology demands more.
Process automation technology is a requirement for effective delivery of accurate, up-to-date content to manufacturers' public and protected websites. TransPerfect also has the technical resources to deliver on that requirement. Our GlobalLink technology is integrated with over 70 web CMS systems including Drupal, Kentico, Liferay, SAP, EMC, and Oracle for seamless delivery of accurately translated content of all types.
Say "No" to Website Localization Challenges with OneLink
Localizing (translating) your website can be a challenge. In addition to language accuracy requirements, regulations may restrict what content is available in each country. Now, there's a way to automatically adjust content on per-country basis and deliver translated content without IT or integration overhead. With TransPerfect's OneLink product, you can say "no" to localization challenges:
Software for diagnostic or therapeutic purposes is regulated as a medical device. Yet despite validation and verification requirements, nearly 25% of device recalls are due to software failures. The process of translating software into multiple languages comes with a specific set of risks that must be controlled to ensure patient safety in overseas markets.
Designing software for international markets requires consideration for data structures, UI layout, and language handling. Unfortunately, many i18n issues only emerge at translation – often, when it's too late to effectively correct. TransPerfect's four-step process for i18n helps to ensure "quality at the source" and defect-free localized software.
We are the only supplier to ensure linguistic resource competence by testing in nine (9) medical device subject matters and two (2) content types. Our advanced visual localization tools are in use with companies such as Siemens, Philips, and Abbott. Our translation process automation platform, GlobalLink, supports agile localization methods.
Patient safety depends on effective verification and testing of medical device software. TransPerfect offers a full range of options, from simple UI verification to complete functional testing services – including plan writing, bug tracking/resolution, and customized documentation.
The future is mobile. In fact, mobile, point-of-use labeling (and other digital content) is the basis for the EnCompass system and mobile app. While the translation effort for apps is generally smaller-scale than other device-related software (due to smaller UI), i18n input and testing for platform responsiveness are even more critical. TransPerfect has the dedicated engineering, production, and test resources to help take your mobile strategy global.
In use with CROs, pharmaceutical, biotechnology, and medical device companies worldwide, Trial Interactive is our flagship
TransPerfect Medical Device Solutions provides third-party linguistic review and verification services to the device industry's leading manufacturers because we carry the only Notified Body endorsement for audit and review of translated content.
TransPerfect provides Audit & Review services for clients who are conducting a one-time assessment of legacy content or verifying quality of existing translation memory assets. We also design custom audit/review programs for clients who want to monitor supplier quality, minimize content risk, or outsource the overhead of third-party review.
Our Audit & Review solutions include validated technology to support in-context review of marketing material, custom grading/scoring of translated content, and a full audit trail of reviewer changes for increased control and compliance.
The medical device industry has seen rapid adoption of e-learning technology in three critical areas:
Training travel for global reps is costly. In-person training is significantly enhanced when your new reps have a solid understanding of product/treatment basics. Professionally localized (translated) e-Learning courses can provide the foundation your international reps need to make the most of your training travel budget.
Product instructions, surgical techniques, informal "how-to" demonstrations, and other clinical guidance is easily communicated using today's e-Learning systems. Localized versions of your courses provide extremely cost-effective support for international markets. And with TransPerfect, you can even create custom-designed certification courses for practitioners to emphasize targeted skills or product uses.
QMS and other regulatory training can be orchestrated quickly and effectively – and with a documented audit trail – by using custom-designed, localized e-Learning courses. Whether as part of an ongoing compliance program, or in response to an urgent regulatory requirement, localized e-Learning courses can be quickly created, localized, distributed, and tracked to ensure demonstrable compliance.
To address the unique requirements of medical device e-Learning localization, we've combined award-winning localization engineering with specialized medical device resources and processes – and even added professional course developers to help design and create your courses for maximum impact. The result? Technically flawless and linguistically fluent e-Learning, in any language, to satisfy your global sales, clinical, and compliance requirements.
As device makers migrate to PLM and other cloud-based inventory management systems (or integrate products and systems from corporate acquisitions), they quickly encounter a problem: maintaining data integrity for product labeling, regulatory, and UDI compliance. Until now, no satisfactory option has been available to address this rapidly emerging issue.
Our approach helped one manufacturer solve a $3 billion inventory and regulatory issue
TransPerfect's EnCompass scanning app and digital publishing platform includes a verified solution to ensure data integrity during migrations between enterprise PLM or ERP systems or into cloud-based, virtualized environments. Our tested approach helped one manufacturer solve a
Recently, Artificial Intelligence (AI) has made rapid advances in a number of areas, including natural language processing. However, successfully employing AI in the heavily regulated medical device industry requires more than just technology – it requires careful consideration. Advanced planning is necessary because not all content types are amenable to AI processing – and low quality AI output can contain Serious Errors (may result in patient harm), even after multiple edits.
With a team of on-staff experts and specially-designed AI engines (customized for medical device content, enhanced with +25 years of translation experience) and certified to ISO 18587 (application of AI in a translation environment), TransPerfect is uniquely qualified to evaluate and produce your content using advanced AI technology. We can perform an initial analysis of your content and provide a strategy for incorporating AI into your translation production process for decreased cost and turnaround. We can also provide guidance for how to make your content more AI-friendly so that you can take best advantage of this developing technology.
Click here to request an AI Suitability Analysis for your content.
Today's global device makers need multilingual support in all communications channels. In addition to printed and digital content, manufacturers often benefit from interpreting (spoken language) support – and on-demand interpreting support requires a combination of expert resources and advanced technology. Our TransPerfect Connect service provides manufacturers with on-demand, subject-qualified interpreting resources for a variety of situations:
Online training for international markets is enhanced when provided in the local language. Remote interpreting services are a cost-effective solution for global language support.
On-demand interpreting can provide valuable call-center support to help meet global post-market surveillance reporting requirements.
Video & Remote Interpreting are an invaluable aid in effective communications between international departments and with overseas partners and suppliers.
TransPerfect has the resources and expertise to evaluate and optimize global processes, implement validated technology solutions, and provide best-practice governance structures to drive quality and financial results. For one life sciences client, our centralization services delivered $15 million in annual savings and a 35% reduction in time to market.
TransPerfect Medical Device Solutions was the first translation practice certified to ISO 13485 (certified to 9001 since 2002) – we hold the industry's most mature, medical device-specific quality system, ensuring full QS parity for our clients. We were the first company in the world to certify to ISO 14971 – our GAP analysis and initial audit cycle were conducted under the direct supervision of Dr. Harvey Rudolph, a 25-year FDA veteran and an original author of the standard. We are the only language services supplier to qualify resources according to nine (9) medical device subject matters and two (2) device content types. We hold the world's only patent (U.S. Pat No 8,140,322) and Notified Body endorsement for labeling translation risk management, and are the largest provider of language services and content automation technology to the medical device industry. EnCompass, our modular system for structured content and process automation, is designed to help manufacturers meet the requirements of MDR and IVDR. EnCompass technology and services are in place and delivering 10 x productivity gains for companies such as Medtronic and Stryker. Most recently, we have added ISO 17100 and ISO 18587 to our unmatched roster of specialized certifications.
Together with our other Life Science production groups, TransPerfect Medical Device Solutions
operates under a defined "Center of Excellence" model:
Linguistic resources are tested in nine (9) separate medical device subject areas and four (4) different device content types. Program resources include Six-Sigma black belts, RA/QA professionals, and senior executives with decades of medical device industry experience.
we offer clients validated, modular technologies that automate content creation, translation processing, and distribution. Our EnCompass system for UDI-enabled digital publishing is endorsed by Jay Crowley, the former FDA Senior Advisor for UDI.
Our validated technology supports comprehensive reporting for a wide range of financial and quality metrics to support improved process management, continual improvement initiatives, and effective strategic planning.
The long-term success of centralization and process improvement efforts rests on management and governance. Our Governance model is based on a three-tiered structure:
Together with designated Global Program and Quality resources as well as client-side Relationship and Content owners, this structure provides a well-defined organization for ongoing collaboration, performance, and improvement.
Successful program design and automation depends on well-structured processes. TransPerfect combines sophisticated diagnostic analysis, including Lean Six-Sigma and Process FMEA, with Notified Body-endorsed best practices to provide clients with practical recommendations for sustainable process improvement. Improvement recommendations are enhanced with validated automation technology for increased efficiency and throughput.
Once processes have been optimized, you can achieve additional benefit and throughput with validated automation technology. TransPerfect's modular technologies can be employed individually or integrated for custom solutions to fit any need. From XML content management systems, to translation process automation, to UDI-enabled digital publishing, and even e-clinical trial systems, TransPerfect is the largest supplier of content management and process automation systems to the medical device industry.
TransPerfect holds the only Notified Body endorsement for audit of legacy translations. In fact, we provide expert, third-party review services for some of the industry's largest manufacturers. Audit & Review services can be employed for:
TransPerfect's Audit & Review solutions include validated technology to support in-context review of marketing material, custom grading/scoring of translated content, and a full audit trail of reviewer changes for increased control and compliance.
New Labeling requirements are extensive: language requirements are now contained in the regulation, meaning sales into local markets must be supported by in-language labeling. Labeling will require more frequent updates to reflect information from expanded post-market activities. New labeling items (such as Patient Implant Cards) and safety reporting are required (and in local language). Software UI is defined as labeling and falls under the new requirements. See "Labeling Translation" under Services & Solutions (below).
Software UI is labeling...and due to the new labeling language requirements contained in Article 10, it will require localization. Many device manufacturers have relatively primitive processes for software translation and may need internationalization support (i.e. code analysis and preparation) to enable their software for localization. See "Software Localization & Testing" under Services & Solutions (below).
Article 20(5) of the MDR mandates the CE Mark for promotional material. It is anticipated that this will drive increased documentation control rigor for Marketing content. Further, Article 7 of the MDR makes explicit that review of promotional material (including websites and social media) for safety or performance claims (compared to data in technical documentation) will continue. Therefore, manufacturers should consider effective methods for ensuring that shared content (between promotional material and other technical documentation) is always in synch. See "Marketing Localization" under Services & Solutions (below).
Many manufacturers have only just begun their MDR & IVDR preparations. In addition to standard gap analyses, companies are assessing their content management systems for adequacy. One IVD manufacturer, facing a labeling-readiness cost of over $1 million, is evaluating system automation to cut 33% of the total cost, while reducing turnaround by 50%. TransPerfect Medical Device Solutions is supporting over $30 million of active MDR & IVDR initiatives.
Although there are 25 specific mentions of "training" in the MDR & IVDR, there is no specific requirement for how that training is developed or delivered. Experts believe that the large number of changes due to MDR & IVDR will drive a significant increase in training requirements. Documented, auditable approaches (such as e-learning) will see increased usage – this content will require translation for use in local markets. See "Award Winning E-Learning Localization" under Services & Solutions (below).
Under the MDD, language translation requirements were left to the Member States. Now, the MDR contains 25 explicit references to language requirements, including a new requirement for "clear comprehensibility" – an indication that translation quality will be under additional scrutiny:
"Manufacturers shall ensure that the device is accompanied by the information set out in Section 23 of Annex I in an official Union language(s) determined by the Member State in which the device is made available to the user or patient... clearly comprehensible to the intended user or patient."
Certain types of content will be reclassified into more restrictive categories – resulting in greater regulatory scrutiny. Some software will be reclassified as a medical device and at a higher risk level. It is therefore likely to receive additional regulatory attention, as will promotional material such as websites and social media feeds.
MDR & IVDR changes are already driving increased volume and velocity of content in the medical device industry. This trend will accelerate in the coming years as manufacturers come into compliance with new language, documentation, and post-market surveillance/reporting requirements. The best way to manage this increase is through automation.
The increase in content volume and velocity as a result of MDR & IVDR will drive increased adoption rates for XML content management (increases content re-use and automates publishing) as well as translation process automation, such as our GlobalLink system.