Medical Device Translation Services

Certified Medical Device Translations

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Our high-quality medical device translation services can help you meet the necessary compliance for your devices including labels, user instructions and installation manuals. We have a global team of dedicated medical device translators who are subject matter experts and can provide certified translations of all your medical documents. 

Every medical device manufacturer looks to global markets and understands that there are stringent regulatory standards that they have to meet to access those markets. In the EU, medical device companies must meet the Medical Device Regulation (MDR) standard from the research and devaelopment (R&D) stage. Our translators are experienced with this regulation as well as other global medical device regulations. 

As a leading translation agency, we can provide certified translations for medical devices including clinical content, technical specifications and safety data.  Each certified translation is accompanied by a statement of truth, signed and stamped by the translator. This attests to the accuracy and faithfulness of the translation as a representation of the original text. 

Certified translations are accepted by all public authorities and private organisations within the UK. Other common law countries such as Canada, Australia and the United States also accept certified translation solutions. However, civil law countries such as most of mainland Europe often require sworn or legalised translations which we also provide as part of our comprehensive language service. 

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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Translating medical device documents and software is extremely important. It allows everyone involved in the device’s lifecycle, from marketers to end users, to understand the materials and paperwork associated with its development, deployment and use. This is imperative for safety and to prevent misuse. 

The area of medical translation is highly specialised because of the use of medical terminology. A translation project for the medical device industry adds another level of complexity with the need for not just medical accuracy but also understanding of technical language. Professional translation by experienced linguists with medical expertise, technical knowledge and understanding of regulatory standards is the only way to ensure that you achieve the high standards you require.

All medical device translation needs to be compliant with regulated language outcomes which vary between national competent authorities. In the EU, because of its multilingual policy, it is even more important to have a language services provider that you can trust to deliver.

What are the regulatory requirements for medical device translations?

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Every medical device translation must meet the standards of the target country’s regulations such as the EU’s MDR. The EU MDR replaces previous directives and covers all medical devices within the European Union market including vitro diagnostic medical devices. 

The purpose of this regulation is to unify compliance within the medical device industry across the EU, with the intention of simplifying adherence to regulations and facilitating international trade. This includes the harmonisation of languages for all associated documents, labels, manuals, post-market reports, clinical content and any other relevant documentation. 

Due to the multilingual nature of the EU, all medical technology paperwork and software needs to be translated into more than twenty different languages. For this you will need expert medical device translation services such as Espresso Translations.

What Documents Require Medical Device Translation?

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Any documentation and software related to a medical device will need to be translated. The following is not an exhaustive list but gives an indication of the range of materials that will need specialised translation. 

• R&D documents, paperwork and files
• Patents
• Device labels 
• Marketing materials
• User manuals
• Clinical content
• Safety data
• Risk management information
• Product and safety updates
• Multinational clinical investigations
• Clinical outcome assessments
• Performance evaluations
• Post-market surveillance

The information needs to be accessible and understood by anyone involved in any part of the lifecycle of the device, from R&D through to the patient using the device. This includes laboratory operators, healthcare professionals, patients and caregivers among others. 

How to Choose a Medical Device Translation Provider?

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Espresso Translations is a respected medical translation agency based in the UK. We have a global network of subject matter experts from within the medical industry. Our team works in more than 150 languages and we only use native translators who translate into their mother tongue. This provides a more natural, fluent reading of the translation. 

Each of our accredited linguists has more than five years of experience in the translation industry as well as extensive knowledge in their own area of expertise. We have translators from a variety of medical backgrounds including life sciences, pharmaceutical research, clinical trials and medical device industry experience.

We’re ISO 17100 certified and GDPR and Privacy Shield compliant. You can therefore have peace of mind that not only will you receive the highest standards of quality but also complete confidentiality and data security throughout the translation process. 

As one of the leading translation companies in the UK, Espresso Translations has extensive industry experience. Our translators are familiar with medical terminology, technical language, regulatory requirements and the need, where necessary, for plain language.

What phases does the translation of a Medical Device include?

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If you require translation of medical device software or documents, contact Espresso Translations via our online contact form. Provide us with your details as well as the type of translation certification you require, the target and source languages and your required delivery date. Don’t forget to upload your project brief. 

From beginning through to completion, the translation process is overseen by your own dedicated project manager who will liaise with you throughout. They will contact you within an hour with a quote for the work and discuss any other relevant details. On acceptance of the quote, your project manager will assign the most qualified person to your project. 

When our linguists translate medical device documents, they follow a series of steps to ensure high-quality translations. When they have completed the translation, it will be sent to another linguist with the same qualifications as the first, who will proofread it. Your account manager will carry out any final quality control checks before sending the completed translation to you for approval.

How long does the translation process take for medical devices?

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There are several factors which affect the length of time that a medical device translation will take. These include:

• Length of the document(s)
• Nature of technical and medical content i.e. complexity
• Language pair i.e. source and target languages
• Format required

Espresso Translations works with speed and accuracy, never compromising the quality of the work and always focusing on meeting customers’ expectations. We understand the delicate nature of medical translation services and the need for precision while meeting deadlines.

Why Choose Our Medical Device Translation Services?

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By choosing Espresso Translations for your medical device translation needs, you will be engaging the services of an agency that fully understands the regulations associated with this industry. 

In addition, our extensive global network of experts not only have the language solutions but the industry-specific knowledge to produce accurate document translations.  This is extremely important as the terminology used depends on the medical area that the device is affiliated with. Therefore, you will need someone who can translate technical documents which are also medically specific. 

Our team is also cognizant of the rules and regulations in various countries including the EU MDR which is designed to harmonize compliance across all member states. We also understand the need for medical device documents to retain their original meaning and context while also being understandable to a variety of readers and users.