Medical translation for the life science field typically involves technical manuals, regulatory documentation, and software applications. Medical translation services should be completed professionally by a translator with expertise in the terminology used in materials.
In most countries it is a requirement that any patient information and labelling be translated.
Regulations from the European Union specify translation as a requirement in order to market a product in a Member State. This applies to labeling, packaging, instructions for use, or any technical documentation.
Clinical trials require translation in order for local clinicians and patients to be able to understand them. Regulatory approval submissions typically must be translated as well.
Countries and regions have many guidelines regarding the appropriate labeling of medical products. For example, in Europe, the CE mark is required, indicating that a product has passed the complex certification process.
When translating medical manuals, there are many issues to consider, from creating single-language or multi-language IFUs to appropriately sorting the index and table of contents.
Consider how to apply symbols and information based on the requirements and quantity of languages supported. Some companies choose to produce multilingual packaging and labeling to reduce the number of SKUs while others produce unique labeling for each target country.
Document your labeling strategy in a style guide to ensure consistency in how products and languages are addressed.
Although raw machine translation is not likely suitable for medical devices, computer aided translation technology can still be applied to make the work of human translators more efficient.
Create and leverage translation memory and build unique glossaries, adding to the quality and cost savings of each project. Translation memory is particularly useful for managing updates and handling the translation of similar products.
Using translation technology that includes a workflow component (like SimulTracker, SimulTrans' translation workflow tool) will make it easier for you to submit translation requests and generate reports.
If you wish to translate the software terms (that is the user interface the medical teams will see on the screen), it is advisable to translate the software first. Once the software is final, the user interface terms can be extracted and used as a reference for the translators to ensure the same terms are used in the manual.
If the software will remain in English, then you must decide whether to leave the user interface in English, or leave it in English and give it a translation in brackets.
If there are button names or labels printed onto the device that will not be translated, it is important to let your translation team know so that translators can work with that knowledge. This can affect certain translation decisions and should be discussed.
Some companies request language service providers to create a separate "back translation" of each medical document translation back into the source language as an additional quality assurance step. Back translations are completed independently by linguists who were not involved in the initial translation and who do not have access to the original source material.
A back translation will never be 100% identical to the source text, rather it helps to identify any missing words, mistranslations or ambiguities that occur due to language nuances. It is worth noting that some review boards and ethics committees advocate using two separate back translations.
This certification differs from the ISO certifications that language service providers may hold. Many pharmaceutical, medical device, and CRO clients request that a translation firm provide a certificate of translation to comply with specific process requirements or simply for extra peace of mind.
Your translation partner should stand behind all of its translators' work and proudly provide a signed certificate (in hard or electronic format) which verifies that the translation is true, accurate, complete, correct and performed to the best of the translator’s ability and expertise.
Translation costs vary by language, typically corresponding to the cost of living in the target countries. For example, translation into Simplified Chinese is about a third of the cost of translation into Swedish.
You should expect to receive discounts based on repeated text and leveraging from the translation memory (in essence you only need to pay to translate content once, not again and again for each update).
To try to calculate a rough total budget, including formatting or testing and other related services, we usually recommend the following formula:
Cost = Number of Languages × Number of Words ÷ 2
Translators usually translate about 2,000 words per day. You can generally accommodate almost any required schedule by adding more translators, but this also reduces consistency. SimulTrans has some projects with over 100 translators per language working simultaneously to translate millions of words in a matter of days.
If you are not in a huge rush, we usually recommend limiting your translation team to three translators and two reviewers per language. A group of this size would complete about 6,000 words per day. Since the translators for all languages work simultaneously the number of languages does not have an impact on the schedule.
Aside from translation, there are usually a couple days for set-up and some time required for formatting and final quality assurance at the end of the project.
Having earned ISO 9001 and ISO 17100 certifications, SimulTrans’ promise of consistency and integrity of work is backed by third-party certifying agencies and can further confirm our long-term commitment to quality.
ISO 9001 certification is a set of quality standards that can be applied to many industries. This certification allows our customers to meet their own certification requirements by providing an assurance to notified bodies and regulatory agencies that translations are completed according to a documented and quality-oriented process. This is especially prudent in the medical industry.
ISO 17100 certification is based on the EN 15038 certification that was designed exclusively for the translation industry by the European Committee for Standardization. This certification aims to standardize terminology, define basic requirements for services, and create a framework for interaction between customers and services providers.
Sound quality assurance practices are vital for the success of translation in general, and even more important when handling medical content.
The life science translation team at SimulTrans is an elite group of dedicated translators with higher education degrees in medical and/or scientific-related studies. They are native speakers, working in their respective target countries, with an average of seven years professional translation experience.
SimulTrans selects linguists and reviewers for each project based on their understanding and experience with the specific subject field (e.g., a cardiac device user manual would likely have a different translator assigned than a clinical trial for in-vitro diagnostics.
SimulTrans recognizes its important role in assisting clients with the proper application, preparation, and understanding of compliance issues when exporting products to new legal and regulatory systems. Our team stays on top of changing regulatory environments all over the world, with particular emphasis on Europe and Asia.
The team regularly reviews new and product specific directives, particularly for Europe’s CE Marking, keeping close watch over the complex certification processes required for medical products and information.
The life science translation team serves as a comprehensive and informed advisor, creating an integrated localization strategy that ensures that products are not only localized well in terms of linguistic style and accuracy, but also prepared to meet the requirements of new or revisited target countries. Once the approval process has been completed and all requirements have been met for export and sale, SimulTrans’ multilingual publishing group has all of the appropriate symbols necessary to finish off your product packaging.
SimulTrans has maintained close relationships with the American Marketing Association, the Medical Marketing Association, and the Regulatory Affairs Professional Society. In addition, SimulTrans maintains membership with several national and international, leading medical industry associations, and informational organizations.
Great team! I've worked with SimulTrans and it is truly a pleasure. Their service has been excellent, and they work hard to ensure that projects are handled with the utmost quality from beginning to end.
Cardiac Medical Device Manufacturer[fa icon="quote-right"]
Best translation service I have used in 20+ years. Great customer service, great price, always on time or earlier.
Bioresearch Products Manufacturer[fa icon="quote-right"]