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Best Practices of Medical Device Translation Services

Posted by Chloe G. on October 22, 2023.

In 2019, the global medical devices market reached a valuation of US$ 447.63 billion, and it is projected to surge to approximately US$ 671.49 billion by 2027. As the medical device industry expands, there is a concurrent rise in the worldwide demand for professional medical device translation services.

Here are the best practices to adhere to throughout the medical device translation process. Our post will generally contribute to ensuring high-quality translations for medical device documentation.

Conduct Comprehensive Market Research

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Before initiating the medical device translation service process, it’s essential to undertake comprehensive market research for each target country. Gain insights into local medical practices, cultural subtleties, and language preferences.

Identify the regulatory prerequisites and any supplementary certifications necessary for market clearance. This diligent research will establish the groundwork for a prosperous medical device translation service.

 

Offer Clear and Concise Instructions

You may already be familiar with navigating the application process of the Food and Drug Administration (FDA) in the United States. However, when it comes to securing approvals for medical devices overseas, be prepared to face additional regulatory challenges.

A reputable medical device translation service can be invaluable in overcoming these hurdles. The key to streamlining this process lies in creating medical device instructions that are clear, concise, and consistent while also keeping costs at a minimum.

Consider the European Union (EU) as a notable example, with its extensive list of language requirements. This highlights the importance of adhering to straightforward, transparent, and succinct translations to help companies avoid complications.

To obtain the coveted CE marking and logo, which signifies that “products sold in the EEA [European Economic Area] have been assessed to meet high safety, health, and environmental protection requirements,” device manufacturers typically need to provide translations of their device’s instructions for use into all 24 official languages of the EU.

 

Make Use of Reliable Medical Writing Techniques

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In terms of medical content, it’s crucial to prioritize clear and concise translations. This entails refraining from the use of acronyms, which can differ between languages, and abbreviations, which exhibit wide variations as well. Steer clear of idioms and overly intricate terminology, as they often do not translate effectively across languages.

Whenever a simpler linguistic option is available to convey the message, opt for it. Furthermore, avoid the use of slang, regardless of the current trendiness of colloquial expressions.

Employing straightforward language will ensure that the translated documents align with the requirements of the EU’s Medical Device Directive, ultimately leading to the attainment of the CE mark.

 

Work with Human Translators with Medical Expertise

While machine translation has its applications, when it comes to translating healthcare documentation, the stakes are too high for medical device companies to risk errors. Translation mishaps can potentially have severe repercussions on a company’s reputation and financial stability.

This is why it is imperative to collaborate with an ISO-certified medical translation company, one that relies on the expertise of human translators with a strong background in the medical field.

Specialized medical device translators act as a safeguard against inaccuracies that may arise from translators lacking medical training. It is advisable to work with translation specialists who possess expertise related to your specific medical device. This extra layer of specialization ensures error-free and easily comprehensible translated content.

 

Make Healthcare Labeling As Clear as Possible

As previously mentioned, it is imperative to avoid using industry-specific terminology and jargon on your product labels.

Furthermore, when crafting (or translating) your device labels, strive for clarity and brevity, ensuring that they are instantly comprehensible in any language.

When regulations permit, consider incorporating well-recognized symbols that transcend linguistic and geographical boundaries, by ISO 15223-1:2016 guidelines. For instance, you can utilize international symbols for “caution,” “manufacturer,” “keep dry,” “fragile, handle with care,” and “biological risk.”

By including symbols whenever feasible, you not only enhance the visibility of your device labeling, which is a fundamental aspect of effective labeling but also reduce the risk of translation errors. It’s worth noting that symbols typically occupy less space than text.

Concise, jargon-free translated content, coupled with symbols and easily understandable images and graphics, can facilitate your entry into foreign markets. This is achieved by making your medical device labeling exceptionally straightforward to comprehend, ultimately leading to decreased translation and quality assurance expenses.

 

Maintain Translation Memory and Terminology Management

To maintain consistency across various projects and versions, it’s essential to have a Translation Memory (TM) and a Termbase in place. A Translation Memory stores previously translated segments for reuse, thereby reducing costs and guaranteeing uniformity in intricate medical terminology.

 

Stay Up to Date with International Medical Device Documentation Requirements

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The significance of remaining current with medical device translation prerequisites in the regions where you operate cannot be emphasized enough.

The medical device sector is extensive, and national regulatory bodies regularly revise and amend local regulations to address new technologies, emerging device sectors, and even trends in the field that may make headlines locally.

Keeping abreast of these changes can be quite demanding, which is why it is advisable to opt for an established medical translation company. Such a company should collaborate with proficient medical translators who possess expertise in managing device regulations across various countries.

 

Find the Ideal Medical Device Translation Company

Not all companies are adequately prepared to address your medical translation requirements. It is crucial to have a team with expertise in regulatory requirements and translators well-versed in medical terminology.

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When you combine this with ISO Certification, exceptional quality and service standards, and an impressive portfolio of clients in the medical device industry, you can establish the foundation for a potentially enduring and prosperous partnership. As a trusted translation agency, GTE Localize has supported various big medical device businesses effectively with our medical device translation services such as Abbott, Bio-rad, Thermo Fisher, and more, you can see our medical device translation portfolio here

Don’t hesitate to reach out to GTE Localize today to start the process.