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?
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.
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.
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.