The medical device industry is highly regulated and demands precise and accurate translations to ensure patient safety and compliance with regulatory requirements. To reach a wider audience, medical device companies with global operations must translate their technical documents, labeling, and instructions into multiple languages.
Choosing a translation provider for medical device industry translations can be a complex process that necessitates careful consideration. Here are some key factors to consider when selecting a translation provider for your medical device industry translations.
Expertise in the Medical Device Industry
It is crucial to choose a translation provider with experience and expertise in the medical device industry. Your provider should be familiar with the relevant regulations, standards, and guidelines, including those associated with ISO 14971, ISO 13485, and the FDA. They should also have a thorough understanding of the technical terminology and language used in the medical device industry.
Qualified Translators and Reviewers
Qualified translators and reviewers are essential for accurate and reliable translations. Your translation provider should have a rigorous recruitment process that guarantees their translators and reviewers are qualified and experienced in the medical device industry. Such linguists should have a deep understanding of the terminology and language used in the industry, as well as up-to-date knowledge of the regulatory provisions for medical device translations.
Quality Assurance Processes
Quality assurance is critical for medical device industry translations. Your translation provider should have a robust quality assurance process in place that safeguards the accuracy and consistency of your translations. Their process should include multiple rounds of review and proofreading by qualified reviewers and editors so that translations meet the highest standards of quality.
Compliance with Regulations
Medical device translations must comply with regulatory conditions in each target country. The translation provider should be familiar with the regulations and requirements for each country and make sure that their translations satisfy them. They should also be able to provide documentation and certificates of compliance to support the regulatory submission process.
Complicating the matter further, the lines between medical devices and the technology industry are starting to blur due to the increasing digitization of the medical device industry. This includes content related to medical devices appearing online, reporting of adverse events connected with post-market medical devices, and the launch of complementary mobile apps or standalone software. High-tech companies are now entering the healthcare market with products ranging from wearable devices to sophisticated mobile apps that can complement or substitute for medical devices. Digital health is a growing industry with smaller companies producing apps and wearable devices for monitoring physical fitness and managing chronic diseases. Bearing all that in mind, your translation provider must be on top of the many rapid industry changes relating to various regulatory agencies and countries.
Translation Technology and Tools
The use of translation technology and tools can improve the efficiency and accuracy of medical device industry translations. Your translation provider should have access to the latest translation tools and technologies, such as translation memory and terminology management systems for consistency and accuracy across all translations. They should also be able to work with your existing translation management system if you have one in place.
The TrueLanguage Difference: Translations and Typesetting in Medical Translations
In the medical device industry, the term “labeling” refers to the content associated with the device, including affixed labels, packaging, IFUs, software, display screens, marketing materials, patient information, and safety/technical information. Typesetting this amount of information in multiple languages can be difficult, but our meticulous typesetting and QA process eliminates mistakes.
Manufacturers must supply a complete set of labels for the device and packaging, along with IFUs and a list of languages for member states where the device will be sold. The information provided must be in an official EU language that is easily understood by the user or patient, as determined by the laws of the member state. This means that a typical EU medical device may require labeling in over 20 languages, which is more than the typical number of mandatory languages in non-regulated industries.
TrueLanguage can handle translations and typesetting into many different languages.
The TrueLanguage Difference: Medical Writing Services
Pharmaceutical companies are known for allocating a larger budget for marketing activities than for research. These companies often need multilingual translation and interpretation services, medical writing services, and communication services for the medical community and the general public. These services include medical writing for specialized or general audiences, regulatory medical writing, the creation of multimedia and editorial products, and graphic design and illustration services. Other entities, such as public institutions, nonprofit organizations, medical associations, communication professionals, and specialized publishers, may also depend upon these services.
In addition to expert translation of scientific and medical text in many different languages through our long-term partnership with a highly qualified network of linguists who are subject matter experts, TrueLanguage also offers medical writing services. We rely upon a proven network of appropriately certified and experienced medical writers who are regularly available for projects.
Summarizing
In summary, choosing a translation provider for medical device industry translations demands careful consideration of factors such as expertise, qualified translators and reviewers, quality assurance processes, compliance with regulatory requirements, and the use of translation technology and tools. It is crucial to partner with a translation provider that has experience and expertise in the medical device industry and can deliver accurate and reliable translations that meet the highest standards of quality and regulatory compliance. TrueLanguage, aside from meeting those standards, can also translate and typeset into many different languages. As a convenient value add, we also offer top-notch medical writers when needed.
When it comes to the exacting world of medical devices and translations, it’s important to make the right choice. Contact us today and experience the TrueLanguage difference.
