Medical Device Translation Services

Certified Medical Device Translations

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Any translation of materials used in the medical field must be done by a translator with special expertise who uses precise terminology supplemented with appropriate quality control procedures, and this is particularly true for medical device translation projects. Medical device manufacturers and users of medical devices should make sure to turn to translators with sufficient knowledge and experience. Those with insufficient credentials should not be trusted to translate user manuals, clinical trial records or other documentation related to these medical devices. To ensure medical devices are properly used, these are tasks best assigned to subject matter experts and translation professionals with specific training in the medical field and knowledge of the associated terminology. 

In fact, such translations often must additionally include a translation service known as a sworn translation. A sworn translation is a translation project for which, after careful completion, the translator attests to the quality of work and its accuracy in front of a judicial officer as a further assurance of its suitability and legality. This is a responsibility that requires a qualified professional translator like the ones available at a well-regarded translation agency such as Espresso Translations.

The following list shows the reasons why medical device translations are especially nuanced and deserving of special care:

• Patient health: Medical and technical terminology must be rendered precisely in the target language to ensure the best patient outcomes. 
• Clear comprehension: Effective communication about medical devices is especially important to ensure that patients and healthcare workers fully understand all instructions and their health implications.  
• Country-specific regulatory compliance: Medical device documentation must be in accordance with the laws in the location where the device will be used.  
• Compliance with MDR requirements: The European Medical Device Regulation (MDR) governs the documentation of medical devices.  
• Cultural relevance: Translation is more than a process of converting words from one language into another. Localization renders the translated material in a way that is appropriate and relevant to the culture of the country where the document will be read.  
• Safety and accuracy: Translated material regarding medical devices must be rigorously reviewed and subject to quality control for the utmost in faithfulness to the original text.  
• Timeliness of delivery: Medical device translations should be done efficiently as well as carefully to meet delivery deadlines.  

The industries and fields involved in medical device translations include:  

– Medical device or surgical instrument manufacturers  
– Companies doing business in the pharmaceutical and pharmacological sector  
– Local health authorities and healthcare professionals  
– Medical practices, hospitals, and clinics

Service Type	Translation services for medical device documentation
Supported Languages	English, Spanish, French, German, Italian, Chinese, Japanese
Specialization	Technical and regulatory terminology for medical devices
Translation Method	Professional human translation with expertise in medical and technical fields
Delivery Time	Variable based on complexity and language (typically 3 to 7 business days)
Accepted Formats	User manuals, technical sheets, certifications, compliance documents
Quality Assurance	Included in the service, with review by experts in the medical industry
Additional Services	Certified translation, localization for specific markets, regulatory assistance

Why Are Medical Device Translations Important?

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The importance of translating medical devices lies in ensuring the following overlapping priorities are addressed:

• Scientifically accurate information
• Providing clear communication of key concepts  
• Patient safety and appropriate use of the device  
• Compliance with the regulations in force 

One frightening example of how high the stakes are for medical device translations is a mistake made in a translation of a manual used by medical practitioners at a hospital in Berlin that converted the original text “non-modular cemented prostheses” as instead “prostheses that do not require cement.” This unfortunate phrasing resulted in 47 patients receiving the wrong knee prostheses!

Not surprisingly, this and other translation mishaps have had consequential legal repercussions as well as significant effects on the health of patients.  

If you work in the life sciences or healthcare field or deal with leading medical device manufacturers and distributors, a trusted translation agency like Espresso Translations with many years of experience in medical translations is an essential asset. High-quality medical device translations are crucial for your business because:

• They provide effective communication for medical device sales.  
• They help prevent errors by healthcare workers.  
• Medical device users are more likely to receive appropriate and successful treatments.

What are the regulatory requirements for medical device translations?

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• In the United States, the FDA (Food and Drug Administration) has implemented precise regulations for medical device translations. The FDA requires manufacturers of medical devices to provide complete, accurate translations of all materials that may facilitate the understanding of their use in order to ensure citizen health. The FDA directs that translations into the official languages of the countries where medical devices will be used must faithfully reflect the intention of the original content in every detail.
• In Europe, the Medical Device Regulation (EU MDR) and the In Vitro Diagnostic Regulation (IVDR) have established specific requirements for producing translations of the documentation for medical devices. The EU MDR and IVDR require manufacturers to provide accurate translations of labels, usage manuals and instructions, and all other materials needed to use medical devices safely and efficaciously. Translations for medical devices must be rendered into the official languages of the member state(s) where those devices are to be sold. Any manufacturers wishing to sell medical devices or products in the European Union must comply with these regulations to obtain the CE mark needed for their sale.
• The International Organization for Standardization (ISO) has enacted medical device standards with its ISO 13485:2016 and ISO 14971:2019 standards. ISO 13485:2016 sets the requirements for a quality management system for manufacturers of medical devices, including translation requirements that demand a system of quality controls and periodic reviews. The ISO 14971:2019 standard spells out the implementation of risk management for medical devices, which specifies translation and localization procedures. Medical device manufacturers must follow these standards to have the necessary materials translated properly according to international regulations.

As a trusted supplier of language and translation services, Espresso Translations fully complies with strict regulatory requirements and is proud to possess all the necessary certifications needed for medical device translations.

Which Documents Require Medical Device Translation?

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All materials documenting medical devices or employed in their marketing and clinical use must be carefully translated by a proven agency like Espresso Translations with the appropriate resources and expertise. Some of the medical device materials that need accurate translation are:

• User manuals and maintenance manuals  
• Labels and markings  
• Packaging  
• Clinical trial documentation and related medical reports  
• Software manuals  
• Marketing materials  
• Patents and technical documentation
• Any other medical device documents

The medical device translators at Espresso Translations are specialists in the medical device industry who can meet all your translation needs professionally and punctually, all at a reasonable price.

How to Choose a Medical Device Translation Provider?

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Considering what is at stake with the translation of medical device materials, we urge thorough caution in choosing a provider of medical document translation services. How is this done, and what should you be aware of? Consider these factors when seeking a good medical device language services provider:

• Look for translation agencies and interpretation providers with ISO certifications, specifically SO 17100 and ISO 13485.
• Check for a solid track record in medical and pharmaceutical translations as shown by customer feedback and years in operation.
• Choose a translation agency that has implemented Quality Assurance (QA) processes to ensure the highest quality translations.

One choice you might need to make is whether to go with a translation agency or a freelance translator. If you are unsure of the criteria for making your choice, consider that:

• A freelance translator will work independently and might offer lower costs than a translation agency, although they might not offer the same range of services.
• A freelance translator will generally do their own quality control after performing a translation. An agency, however, can use multiple proofreaders to achieve accurate medical translations.
• A translation agency can employ multiple translators on a project to ensure faster turnaround times.
• A translation agency is likely to have many linguists who work in different languages, whereas a freelance translator typically only works with two specific languages.

When you are in the market for dependable, expert medical device translation solutions, Espresso Translations can provide you with quick services and exacting standards at a competitive price.

What phases does the translation of a Medical Device include?

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A translation project can be broken down into a number of steps or phases. With an important medical device translation, the steps are as follows:

• First, a careful reading of the original text. This step calls for expertise in the source language, all technical terminology, and every cultural and medical nuance in the original document.  
• Then, a consideration of the target audience for the medical device materials. This takes into account the target audience’s language skills, cultural context, level of medical knowledge, and more.  
• An important step is the analysis of the document’s regulatory requirements, for which the translator must have a thorough understanding of all European Community and extra-European medical device regulations.  
• The translation itself is the actual linguistic conversion of the medical device content. This must be done by a linguist with medical expertise for the best professional results.  
• Localization services are often a part of the translation. Localization means an adaptation of the translated content to meet the language, cultural, and regulatory requirements of the target audience. Illustrations and instructions can benefit the most from a competent localization phase to improve the impact of the translated document when read by the healthcare worker or patient.  
• Next is review, validation, and quality control. Proofreaders and editors work on this critical step for translation accuracy.  
• Finally, there is delivery, followed by post-translation support as needed. A reputable translation agency will always respond to any client requests for clarification.

How long does the translation process take for medical devices?

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A number of factors can affect the length of time necessary to complete a professional medical device translation. These include:

• The length (number of words or pages) of the material to be translated  
• The type of material to be translated: complex medical terminology requires expertise  
• The specific source and target languages 
• The technical complexity of the material 

The main determinant of the time needed for a medical document translation will usually be the length and medical complexity of the content. Translators of commonly used languages are often available more rapidly, but a suitable translator may not be available immediately when a rare language is involved.

At Espresso Translations, our professional translators are all native speakers with experience in medical, pharmaceutical, and medical device terminology. Our certified medical translators have a proven track record and focus on delivering timely and accurate translations. Keep in mind that you may be able to get expedited service for tight turnaround times; just use the Espresso Translations contact form to tell us what you need. Send along the document to be translated, mentioning any special services you need, and you will receive our no-obligation quote for your translation, including prices and turnaround times, in just a few hours!

Why Choose Our Medical Device Translation Services?

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There are many variables in the medical device translation industry, but you can always count on Espresso Translations to provide the best translation services while avoiding the pitfalls you might encounter with other translation providers. We are professionals in the translation field and can help you avoid problems thanks to our experienced project managers.

The expert linguists and other staff at Espresso Translations come to work every day to offer our clients quality medical translations and peace of mind. Over the years, we have built our reputation for delivering high-quality translations every time, through our strengths in:

– Our team of native language translators specializing in medical and medical device regulation
– Expert compliance with major international standards affecting the medical device sector
– Providing computer-assisted translation software to ensure consistent terminology
– A transparent, competitive pricing policy

If you wish to get a quote, or have a question for our team, please feel free to contact us at any time. We will promptly send you a quote, absolutely free of charge, and we pride ourselves on our excellent customer service.