4 best practices for medical device document translations
Whether translation is needed for medical devices or documentation, the medical industry is fraught with unique challenges and strict regulations. For example, regulated by The Center for Devices and Radiological Health (CDRH), a component of the Food and Drug Administration (FDA), U.S. medical device safety and effectiveness regulations are considered to be some of the most stringent in the world.
The ability to stay on top of and adhere to regulatory approval processes, registration procedures, and language and translation criteria is compounded when marketing and selling medical devices globally. But, while compliance and regulations may differ between countries or regions, the one thing they have in common is the need for high-quality medical device documentation translations.
The medical device industry is expected to grow to $612.7 billion by 2025, which means there’s also an increasing need for quality translations of medical device documents. Although translation excellence should always be expected, this is one field where accuracy can’t be underestimated. A seemingly innocuous medical mistranslation can have life-threatening and costly results.
Here are four key language translation best practices for medical device document translations that will help you achieve fast and accurate language translation, while keeping cost under control.
Use translation best practices for successful entry into foreign markets
When entering new global markets, language translation should be included in the business plan and not as an afterthought. The following medical language translation best practices are designed to help you achieve high-quality translations – the first time – and avoid additional costs due to inaccurate or incomplete translations or files that needed to be translated and weren’t.
1. Know what needs to be translated and into which languages: This is one area where change is the only constant. Take for example the upcoming European Union Medical Device Regulation (EU MDR) mandates that expand the scope of what medical devices and documents will require translations, as well as the languages for translation.
To avoid costly delays and cost overruns, you should always plan on translating patents, study protocols, staff documentations, case reports, adverse event documents, drug dossiers, regulatory and legal documents, packaging and labels, instructions for use (IFU), specification sheets, etc.
2. Use translation technology: We’ve all heard why machine translation (MT) is inadequate to accurately and consistently translate documents that contain industry-specific terminology, such as is found in the medical field. Although the technology is improving, the need for professional translators is still of vital importance.
By combining MT with a translation memory and professional translators, thousands of words per second can be translated, while maintaining exceptional quality.
3. Develop a glossary: Whether created by you or in conjunction with your language service provider (LSP), the need for a glossary is critical. The medical field is laden with challenging terminology, not to mention the emergence of an ongoing stream of new terms. For example, new drugs, clinical trials, diseases, medical devices and therapies are introduced with regularity.
A glossary contains all critical terminology and shouldn’t be considered a one-and-done activity. As new terms are introduced, the glossary needs to be updated to always ensure accurate and consistent translations. An added bonus of a glossary is translation speed. With a glossary in-hand, a professional translator won’t need to spend time researching words, phrases or background information – improving quality and saving you time and money.
4. Rely on professionals: In a field as complex and dynamic as this, not to mention the potential of legal and life-threatening ramifications of flawed translations, you need more than a generic language translator. What are some potential outcomes of not seeking high-quality, industry-specific language translators? In addition to legal risks such as when an inaccurate translation for a medical device or medication use results in bodily harm or even death, bringing devices and medications to new countries requires adherence to stringent rules and regulations. Inaccurate, incomplete or inappropriate translations could result in disapproval, costly delays and fines.
This highly-specialized field requires professional translators that will often have an advanced degree in the medical field and are dedicated to the life science industry. This combination of both industry experience and linguistic expertise ensures fast turnaround time of the highest quality medical device translations.
Regardless of the country or region you’re planning to enter, there will be local regulation approval processes, registration procedures and language translation requirements. To successfully overcome these hurdles, you need an LSP that specializes in the life sciences industry.
If you’d like to learn more about how BURG Translations helps you ensure high quality medical device document translations, contact us today.
