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Medical Devices Translations

Our high-quality language services are in full compliance with Regulation (EU) 2017/745 – Certified to ISO 13485:2016 Medical Devices Translations & Text formatting and paging for Medical Devices documents

Are you looking for a company offering reliable medical device translation services? Working with clients in the life science industry, we will provide accurate, up-to-date translations of all your technical documents, labelling, and other medical device content.

With 25 years of experience, we have translated more than 0.7 million pages in over 75 language combinations for more than 250 clients.

Our high-quality language services are in full compliance with Regulation (EU) 2017/745, ISO 9001:2015 and ISO 13485:2016 Medical Devices Translations & Text formatting and paging for Medical Devices documents standards. Following ISO 17100:2015 Translation Services requirements, we will also provide a Certificate of Accuracy upon request, giving you total peace of mind.

What are the main challenges of producing high-quality translations for medical devices?

Translating medical device documents can be a delicate affair for manufacturers and project managers, as well as quality and regulatory managers. Not only do the rules and regulations differ from one country to another, but the terminology used is also very specific depending on which specialist area relates to the device.

What types of documents do we translate?

  • MSDS
  • IFU’s
  • Product catalogues
  • Installation manuals
  • Training booklets
  • Patents
  • Clinical trials
  • Preclinical and clinical evaluation reports
  • Device labelling
  • SOPs
  • Procedures

Medical device translation services that meet regulatory requirements

As a global medical translation agency, Intertranslations has been dedicated to helping major medical device companies achieve their regulatory and export targets since 1996.

With 25 years of experience, we provide high-quality translations that meet all your requirements.

Does ISO 17100:2015 Quality Management System certification cover new regulation requirements?

Yes, it does. As an ISO 17100:2015 certified translation agency, we only employ native linguists with specialist knowledge and expertise in life sciences.

Our specialist team of scientific translators have a wide range of academic and professional experience, from physicians and health care professionals to technical writers in the medical device industry. We only select linguists who have a proven track record that demonstrates their expertise, helping ensure the quality of your translations.

We are also ISO 13485:2016 certified for medical devices. This standard recognises that translations play a vital role in protecting the quality of medical devices.

Although this is not required, we want to give our clients the confidence that our translations follow the strictest standards. At Intertranslations, we take our responsibility for human life seriously.

Do you have tight deadlines?

We are fully aware of the importance in keeping to time restrictions and submission dates when handling documents relating to life sciences. We can meet your deadlines by creating teams of professionals dedicated to working on your project, ensuring both speed and accuracy.

Do your source documents contain scans, photos, diagrams and signatures that cannot be edited?

Our graphic designers have the expertise needed to extract text contained in any non-editable documents. After extracting the text, they send it to our translators. We then deliver the document back to you, containing the text in the target language.

Would you like to receive back the files you sent in the same file format?

We can deliver the document back to you in its original format, along with a PDF. Whether you have .po, .pptx, .xls, .jpeg or .vsdx files, we use software that lets us work with almost any type of document.

Concerned about confidentiality?

We take security very seriously. We are ISO 27001:2013, Cyber Essentials Certified and GDPR compliant. All our staff, both internal and freelancers, sign non-disclosure agreements (NDAs).

Need a translation agency that can guarantee quality and has indemnity insurance?

We cover our services with a 10 million GBP indemnity insurance policy. We are very happy to say that in our 25 years of operation, we have never made a claim.

How do we charge for a translation?

We quote per project, on a per word basis. This excludes the cost of repetitions. We use specialised translation management tools to analyse files and find any repetitions, so you will only be charged once for the translation of repeated text.

We create translation memories for your project and a glossary of key terms. This means that whenever you send new files for translation, we can cross check the content against your previous translations and only charge for new content.

Using specialist translation software, we deliver a fair pricing system that helps control the cost of your medical device translation.

TESTIMONIALS

Communication and public affairs Manager at MSD

Intertranslations and MSD have collaborated on translation projects for medical and pharmaceutical documents, specifically clinical research and medical training materials. During our partnership, we have received approximately 150 pages of translated content. We can confirm that Intertranslations provides high-quality translations and has always delivered on-time or earlier.

Onassis Cardiac Surgery Center

We would like to thank Ιntertranslations very much for their cooperation. We appreciate the effort you put to meet the requirements we set.

Head of Procurement and General Administration at Bayer

We have collaborated with Intertranslations on the translation of various medical and pharmaceutical documents, including clinical research and training material. Completing more than 500 pages of translations on our behalf, they have exceeded our standards of quality and have always delivered within our requested delivery period.

Procurement Manager at Janssen – Cilag

We would like to thank the Intertranslations team for the fruitful collaboration that our companies have had over the past 3 years. During this time, your services have extended to different translation projects concerning medical, scientific, and legal documents. We have outsourced roughly 400 pages to your teams, who have provided fast, quality work that meets and exceeds our standards. We would also like to thank you for dealing with urgent turnovers so efficiently. We have confidence that the Intertranslations team will be there to help and support us during tight deadlines and stressful times.

Clinical Research Manager, Pfizer

Intertranslations has been working in collaboration with Pfizer Hellas as a translation service partner. They have completed translations of multiple documents on our behalf, such as clinical research protocols, training materials, and various other medical documents. Over the course of our collaboration, Intertranslations has completed approximately 10,000 pages of translations. The quality of their translations has exceeded our standards, and their deliveries are flexible and timely.

Translation Solutions we offer you

Translation Editing Proofreading (with certification if required)

We can deliver a certification of accuracy according to the quality standard ISO 17100.

This service includes Translation, Editing and Proofreading by native speakers and subject matter experts.

Post Editing

This service includes Advanced Machine Translation and then Editing of the machine-translated text by specialised Post Editors

According to your needs, you can select if you would like to use one Post Editor, or Post Editor and Revisor

Advanced machine Translation

We have trained neural translation machines using the thousand hundreds pages of text that we have translated in over 25 years.

Neural machines can recognise similar content and provide a draft translation.

Even though not fully grammatically or terminologically correct, it still may be the perfect solution to save time and budget.

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