White Globe provides ISO 13485:2016 certified medical device translation services in over 350 languages. We help the world’s leading medical devices companies achieve international success one language at a time.
The medical device industry is witnessing a major trend toward computation and software driven devices to achieve the best patient experience and improved treatment outcomes. For example, new software enabled devices approved by the U.S. FDA now automatically deliver the exact dosage of insulin to Type 1 diabetes patients without requiring manual intervention. Successful software integration is increasingly the key to achieving higher device quality and lower costs. The same is true for translation services that must leverage the latest agile and data-driven language technologies to support medical device localization for improved efficiency and quality.
White Globe’s leading translation technology platform and translation management system automates the entire language translation workflow and allows medical device manufacturers to obtain quality translations of software applications, device labels, and product documentation with speed.
White Globe uses AI and big data to improve the efficiency of professional human translation services so we can consistently deliver the highest linguistic and technical accuracy, while at the same time achieving very fast project turnaround. Our technology enabled translation ecosystem automatically leverages translation memory, applies medical terminology, and validates translation consistency for localization results that are better than ever.
White Globe Life Sciences Solutions enable our clients to succeed globally with simpler, faster, and better medical device translation services. Quality medical device translation requires more than just linguistic knowledge and technical expertise. This is because the medical devices sector is a highly regulated industry and quality language translation services must follow stringent regulatory guidelines, government directives, and strict technical documentation procedures in order to produce consistent, accurate, and regulation compliant translations for IFUs, labelling, and user manuals.
White Globe understands these medical device translation requirements and our years of localization experience, coupled with our vast quantity of pre-approved medical translators and subject matter experts, allow us to deliver the highest quality medical device translation services on-demand.
Medical devices translation requires the highest linguistic quality and technical precision. Don’t entrust your medical device translations to amateurs or semi-professional agencies. Inaccurate translations not only can delay your international product launch, but can even lead to potential misuse resulting in millions of dollars in damages. White Globe’s certified medical translation service delivers absolute precision and linguistic quality you can trust, allowing you to effectively manage global regulatory risk and confidently communicate with international customers, physicians, doctors, and patients around the world.
The European Union (EU), US FDA, and other governmental regulatory bodies have strict technical documentation requirements for medical devices that are marketed and sold in their respective markets. In most cases, a large quantity of the materials must be translated and presented in the country’s native language to meet compliance requirements. White Globe provides comprehensive translation solutions for all types of medical device content, including design documents, manufacturing guides, operational instructions, compliance declaration, marketing, IFU, and customer training materials.
• Medical Device Marketing Materials
• Medical Device Technical Decryption
• Medical Device Design Dossier
• CE Marking Technical File
• Medical Device Directives Translation
• Declaration of Conformity
• Assessment Procedures
• In Vitro Diagnostic Device Labelling
• Instructions for Use (IFU) Translation
• Device Labels Translation
• Operation Procedures
• Medical Device Training Manuals
Modern medical devices increasingly use sophisticated software applications to manage and conduct advanced operations. This is why most medical device translation projects today involve some levels of software localization (or L10N), a process that extracts the software user interface (UI) strings into external resource files, translates the strings into the required languages, and recompiles them back into the localized application. In addition to UI string translations, the translation service provider must perform linguistic validation or linguistic quality assurance (LQA) as well as functional and cosmetic testing to ensure the localized software is fully operational.
At White Globe, we have the developed mature software localization methodologies and streamlined L10N processes to ensure that your medical device software is localized with the highest quality and speed. Our agile translation process is purposely designed to meet today’s iterative software development process. White Globe is able to most efficiently localize all medical device software types including mobile, embedded, and web based.
White Globe simplifies medical device software language quality assurance onto an easy-to-use mobile-based platform that fundamentally changes the way translation reviews are conducted and managed. Specifically, the White Globe mobile LQA solution is a platform based system that allows linguistic reviewers and subject matter experts to easily and confidently check translation quality anywhere and anytime from their computer, tablet or mobile phone. Compared to conventional translation review processes, our mobile-based LQA model has the following advantages:
1) Agile, flexible, and fast, ideal for today’s iterative software development processes.
2) Simple and easily accessible everywhere and around the clock, for language reviewers and industry subject matter experts alike.
3) Easy linguistic review in context by simply swiping from left to right.
4) Easy linguistic evaluation against established QA metrics by simply swiping from right to left.
5) Better LQA accountability. White Globe mobile LQA is segment based so it can easily track and monitor all linguistic review activities such as time spent checking each pair of segment and percentage of changes.
6) Automatic LQA reporting via API for machine learning and MT training.
Technical documentation required by the EU Directives and other regional authority guidelines specifically include provisions for translating Instructions For Use (IFU). As the name suggests, IFU is the description of a medical device’s intended purpose, such as the target patient population and medical conditions, method of use, or if the device is intended for professional use by doctors, physicians, medical practitioners, or patients themselves. Furthermore, IFUs must be kept up to date to capture any information changes during the product’s lifetime.
In terms of translation services, IFUs must be translated accurately to prevent misuse by the intended operators. In addition to technical accuracy, the translated content must be linguistically fluent and regulation compliant. All of these requirements mean the translation vendor must have the experience, regulatory compliance knowledge, and language technology solutions to produce consistent quality results with speed.
White Globe is ISO 13485:2016 certified, which is an international quality standard specifically developed for medical devices companies and their suppliers to consistently meet customers’ quality requirements.
Together with the instructions for use, medical device labels must be translated to be regulation compliant when the product is sold in international markets. The labelling documentation should show clearly where particular information will be provided and descriptive and information literature that companies the devices. There are many regulatory requirements governing the design and implementation of medical devices labelling.
According to the FDA and International Medical Device Regulators Forum (IMDRF), the use of SaMD in healthcare services has been rapidly growing on a global scale, leading to increased demand for SaMD localization for both European and Asian languages.
You’ve spent much time and effort to develop the perfect SaMD software in English, the last thing you want is to work with an average translation company to distribute your SaMD software in international markets, this is why you need White Globe.
We combine excellent domain experience in software localization and deep medical device knowledge to deliver the best SaMD translation solutions. Our SaMD translation solutions include UI string localization, linguistic and functional testing, and online help and user documentation translations.
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