Medical Device Translation 

Ensure regulatory compliance and accuracy with our medical device translations.
Translations with the highest standard of accuracy delivered by expert linguists in 70+ languages.
Medical device translation

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Need for expert medical device translation


Medical device translation
Medical device translation involves translating documents that are specifically related to medical devices. It includes translating IFUs, packaging & labelling, operation manuals, safety instructions, regulatory documents, and more.

With strict MDR language requirements, medical device translation has become a compulsion to produce and import medical devices in countries of the European Union.

Accurate translation is essential for all stakeholders involved in the process, from manufacturers to regulatory authorities and medical professionals. It helps overcome language barriers at various stages and facilitates effective communication.

According to a study on language barriers in healthcare, 50% believed that language barriers contributed to a higher risk of errors. This emphasizes the necessity for accurate translation services in the medical industry.

Certified Translation Company

Certified Translations

ISO 17100 Certified translation company

ISO 17100:2015 Certified Agency


70+ Languages

We provide medical device translation for any device 


Diagnostic devices

Imaging Devices

Surgical instruments

Monitoring Devices

Rehabilitation devices

Dental devices



Endoscopy devices

Orthopedic devices

Respiratory devices

Cardiovascular devices

ISO 17100 Certified translation company
ISO 17100:2015 CERTIFIED
Milestone Localization is certified by the International Organization for Standardization (ISO) for having in place strong security of information and quality management systems for “End to end translation and localization services.”

We consider the ISO 17100 certification important and demonstrate our commitment to the needs of our customers worldwide.


The European Union Medical Device Regulation ( EU MDR) intends to ensure a high degree of safety and quality for medical devices manufactured in or supplied to EU member countries.

It is the responsibility of the manufacturers to comply with translation requirements and provide translations of all necessary documents accompanying the device in one or more official languages of the EU member states. The translated materials must be precise, and the source language must also be clear.

The primary information commonly required includes product details like labelling, packaging, and Instructions for Use (IFU). Other information, such as user manuals, product safety documentation, etc., are also subject to language requirements.

With our team of expert professionals and the use of advanced technologies, we can provide precise translations that comply with MDR.

A free and comprehensive guide to help you seamlessly navigate the new language requirements as per the European Medical Device Regulation.
A guide to medical device translation as per EU MDR

Accurate Medical device Translation for any document

  • Medical device packaging
  • Medical device labelling
  • Instruction for Use (IFUs)
  • Medical device operation manuals
  • The user interface for medical software
  • Safety data sheets (SDS)
  • Regulatory documents
  • Marketing materials
  • Clinical training materials
  • Patents
  • Intellectual Property Documents


Medical device translation


“When it comes to Translation Services, there are a number of companies that talk a good game, but Vinit and his team from Milestone Localization make it happen! They have facilitated Central Test to advance on projects effortlessly and on time while providing quality services. They take this further by accepting and implementing recommendations whilst upholding a personal connection with us.” 
Medical Device Translation Services

“We have been working with Milestone Localization for over a year now and the experience has been great. The team is prompt in delivering the final content, extremely understanding & supportive in accommodating last-minute changes, and always eager to suggest improvements. It’s a pleasure working with them.” 



Medical Device Translation Services
“I would like to take this opportunity for thanking your entire team for a great turnaround without compromising quality on the recent Branchx project. Your team’s dedication and hard work on the project despite the multiple iterations requested is commendable without which we would not have completed the project on time. Thank you again for the extraordinary support and looking forward to working with your team in the future.”
Medical Device Translation Services

Powered By Technology Translated By Humans

Machine Translation

We use NMT and MT to translate large volumes of data. Translations are post edited and throughly checked for quality by linguists

Language Intelligence

Previously translated segments are automatically matched, helping to save time and money and boost efficiency and productivity.

Terminology Management

Key terms and phrases are identified and saved for each, helping maintain quality and consistency across documents and files

Automated Tracking

Upload documents, get quotes, track progress, download translations and view invoices from your secure customer portal


We understand medical device translation requires a high level of precision and expertise, which is why we select expert linguists best suited for each of your projects after careful consideration.

We have a robust process in place, including proofreading, editing, quality assessment, and typesetting to ensure our translations are of the highest quality.

If you are looking for a dependable translation partner for your manufacturing translation, we are here to help.

By partnering with us, you get –

  • A dedicated project manager for each project
  • Native translator with domain expertise
  • Quality assessed accurate translations delivered on time
  • Unlimited revisions to translated content based on your feedback
  • Translation certificate accepted by all regulatory authorities

Order your Medical device  translations here

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How much do medical device translation services cost?

The medical device translation cost varies according to the word count, type of content, language pair, and turnaround time. Get in touch to get a free quotation.


How long does medical device translation take?

The time taken to translate a document related to medical devices depends on the complexity, length, language pair and overall nature of the document. We can provide you with a timeline after an analysis of your project. 

Can you handle the translation of medical device documentation according to MDR guidelines?

Yes, we work with a team of subject matter experts and highly qualified medical professionals for our medical translation projects.

Our team is well aware of MDR’s intricacies and is well-versed in the terminology, documentation requirements, and translation standards demanded by MDR. We are also ISO 17100 certified and we provide a digitally signed certificate that can be used for regulatory purposes.


How do you ensure that the translations meet MDR requirements?

We have a comprehensive translation process, including proofreading, editing and quality assessment. Our highly qualified subject matter experts meticulously work on each step of the process to ensure that our translations meet MDR requirements.

We ensure that our translations align with MDR standards, helping our clients navigate regulatory challenges seamlessly.

Will translation certificates be provided for my translations? If yes, will regulatory authorities accept your translation certificates?

Yes, we provide translation certificates that certify the accuracy and completeness of our translations. As an ISO 17100-certified translation agency, our translation certificates are authentic and accepted by regulatory authorities worldwide.

How do you maintain the confidentiality of the data?

Maintaining confidentiality of the data is of utmost priority to us. We use the latest technology, strict non-disclosure agreements and conduct regular audits to ensure confidentiality and data security.