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 risk-based, patented language services with validated technologies to provide you with a higher order of translation and content management solution.
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 risk-based, patented language services with validated technologies to provide you with a higher order of translation and content management solution.
Services & Solutions for
MDR/IVDR Compliance and Cost Savings
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.
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.
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.
EnCompass System for
MDR/IVDR Compliance & Cost Savings
EnCompass is a modular solution that includes XML content management technology, automated translation processing (available with AI-AssistedTM Translation and business intelligence reporting), and UDI-enabled digital publishing and master data management.
Services & Solutions
for Medical Device Makers
(Click on a block to learn more about that service)
Labeling Translation
Marketing Localization
Patent & Legal Services
Corporate Communications & HR
Quality Systems Parity
for Device Makers
Localized
Video for International Markets
UDI-Enabled Digital Publishing
Automation for Website Localization
Software Localization & Testing
E-Clinical Solutions
Award-Winning E-Learning Localization
Audit & Third-Party Review Services
Master Data Management & Remediation
AI-Assisted Localization
Video & Remote Interpreting
Validated
Content Management
Process Automation
& Digital Publishing Technology
UDI-Enabled
Digital
Publishing
E-Clinical
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 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
Labeling Translation
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 to take best advantage of the mobile publishing technologies of tomorrow.
Marketing Content
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:
Resources
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.
Best Practices
For Market Input
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.
Technology for
Input Automation
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.
TransPerfect's best-practice solutions for marketing content position clients take full advantage of emerging technologies for direct-to-user mobile ordering for increased user engagement... and revenue.
Patent & Legal Services
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.
Global Patent
Solutions
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.
Contract
Solutions
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.
Litigation Support
Solutions
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.
Corporate Communications & HR
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.
Benefits of Multimedia
for International Markets
"Video marketing is an incredible way to create content that is personal and has a real impact on your audience. It has an incomparable ability to create emotion driven sales...."
~ Forbes Magazine
Manufacturers across all industries (including medical device) are recognizing the benefits of video. According to HubSpot:
- Embedded videos in landing pages can increase conversion rates by 80%
- 87% of online marketers are currently using video content in their digital strategies
- 59% of business decision-makers would rather watch video than read an article
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:
Transcription
and QC
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.
Translation
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.
Recording
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.
Post-production
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!
UDI-Enabled Digital Publishing
"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... 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."
~ Jay Crowley, former FDA Senior Advisor for UDI and VP of UDI for USDM
Major device makers are leveraging UDI and the modular EnCompass system to meet critical business requirements and support UDI-enabled digital publishing:
- Master Data, Supply Chain & Labeling Management – The EnCompass UDI scanning app ensures that product is correctly labeled and registered in FDA's GUDID as well as manufacturers' PLM or ERP systems. Our tested approach helped one manufacturer solve a $3 billion inventory management and regulatory compliance issue and saved tens of millions of software costs in the process.
- Direct, Mobile Ordering – The UDI scanning app (customized for home or hospital user) points to manufacturers' online ordering systems for seamless online sales.
- E-Labeling and E-Marketing – The EnCompass mobile app delivers point-of-use labeling, along with easy access to training or testimonial videos and all other digital product content.
- Automated Content Processes – Cut content cost, risk, and turnaround by 50% (or more) with XML content management for automated publishing and automated translation processing.
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.
Automation for Website Localization
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:
No upfront software fees
No system integration required
No source files required
No software to install
No IT support required
Software Localization & Testing
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.
TransPerfect Medical Device Solutions offers a full-lifecycle solution for software localization and supports medical device manufacturers with industry best-practices through:
Internationalization
(i18n)
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.
Localization
(L10N)
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.
Verification & Validation (V&V)
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.
Mobile App Localization
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.
E-Clinical Solutions
In use with CROs, pharmaceutical, biotechnology, and medical device companies worldwide, Trial Interactive is our flagship
- E-Feasibility
- Study Start-Up & eTMF
- Investigator Portal & Database
- Document Management System
- LMS & Training Management
Audit & Third-Party Review Services
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.
Award-Winning E-Learning
Translation & Localization
The medical device industry has seen rapid adoption of e-learning technology in three critical areas:
Sales
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.
Clinical
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.
Compliance
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.
"Thank you for your continued support and the amazing changes that have made the [e-learning] translation process faster and more affordable for our business units, it is greatly appreciated!"
- Cook Medical
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.
Master Data Management & Remediation
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
AI-Assisted Localization
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 and enhanced with +25 years of translation experience), TransPerfect is uniquely qualified to determine if your content could benefit from 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.
Video & Remote Interpreting
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:
Training
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.
Post-Market Surveillance
On-demand interpreting can provide valuable call-center support to help meet global post-market surveillance reporting requirements.
Corporate Communications
Video & Remote Interpreting are an invaluable aid in effective communications between international departments and with overseas partners and suppliers.
Centralization Programs
Analysis, Design, Implementation, and Governance
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.
Certified Systems, Patented Processes
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 content automation, UDI-enabled digital publishing, and master data management has been recognized by FDA's Senior Advisor for UDI, Jay Crowley: "It's no exaggeration to say that systems like this are why UDI was created." EnCompass technology and services are in place and delivering 10 x values for companies such as Medtronic and Stryker. Most recently, we have added ISO 17100 and ISO 18587 to our unmatched roster of specialized certifications.
Center of Excellence Model
People, Processes, Technology, and Performance
Together with our other Life Science production groups, TransPerfect Medical Device Solutions
operates under a defined "Center of Excellence" model:
People
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.
Processes
Certified to
Technology
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.
Performance
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.
Governance
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:
- Executive Committee (EC) – executive sponsorship, including partnership goals, strategic objectives, and continuous improvement initiatives, is provided by a designated EC
- Steering Committee (SC) – proposes goals and strategic objectives to EC, evaluates overall performance analytics, serves as escalation point for BOC, supports continuous improvement initiatives
- Business & Operations Committee (BOC) – ongoing operational oversight, including KPI review and assessment, financial and quality performance, is provided by designated BOC
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.
Process Optimization
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.
Process Automation
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.
Audit & Review
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:
- One-time assessment of legacy content or translation memories
- Ongoing assessment of translation suppliers as an integral part of a regular labeling audit program
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.
What are the new Labeling requirements?
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).
Does software need to be translated/localized?
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).
Is Marketing content affected?
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).
How are other device makers approaching MDR/IVDR requirements?
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.
Will training and e-learning material be affected?
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).
What are the new language requirements?
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:
Article 10:
"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."
What types of content will EU regulators focus on?
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.
How will MDR/IVDR drive technology changes?
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. It will also increase adoption rates for new types of UDI-enabled technologies that leverage the mandated UDI architecture for direct-to-user content distribution and master data management.
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