Translations for the medical technology sector
Translations for the medical technology sector – ready for regulatory approval in every target language.
Technically accurate, compliant with regulations and available in all relevant languages – so that your products can be approved and used safely worldwide.
In medical technology, every word counts
Medical technology documents are not ordinary texts. Instructions for use, clinical trials and regulatory approval documentation must convey exactly what is stated in the original in every language – not just approximately, but precisely. Incorrect technical terms or unclear wording can jeopardise patient safety, delay the authorisation process for medical devices and block market access to new target markets.
Added to this is regulatory pressure: the European Medical Devices Regulation (MDR) and the In Vitro Diagnostic Medical Devices Regulation (IVDR) impose stringent requirements on documentation – and therefore also on its translation output. If you wish to tap into international markets, you will need a translation service provider that incorporates your specific requirements relating to these regulations into its processes.
These clients put their trust in oneword:
Our certifications:
Taking your medical products to international markets
Consistent use of terminology across all documents
Medical technical terms must be used consistently in every language and across all documents. oneword utilises active terminology management and translation memory systems that store your specific terminology and ensure it is used consistently – from the very first instruction leaflet right through to the latest product revision.
Ready for approval in any target language
MDR, IVDR, ISO 13485 – regulatory requirements in the medical technology sector are complex. Our process management and quality assurance systems are designed to identify and implement all customer requirements and to verify compliance with them. In the medical technology sector, this is a fundamental requirement for the usability and approval of translations in the target country.
Native-speaker translators with specialist knowledge
When it comes to translating your medical documents, language proficiency alone is not enough – specialist knowledge is crucial. Our translators have in-depth specialist knowledge in their respective domains, ranging from imaging and implants through to laboratory diagnostics. This ensures technical terms, procedures and safety instructions remain just as clear in the target language as they are in the original.
All formats – with no detours
Whether it’s InDesign, FrameMaker, XML, XLIFF or DITA – oneword processes all common file formats used in technical documentation. On request, we can also provide a DTP service to ensure your documents are layout-accurate in the target language and ready for printing.
Medical technology documents we translate for you
Technical documentation:
Instructions for use, operating instructions, product data sheets, HMI texts, maintenance and installation guides
Regulatory documentation:
Technical documentation in accordance with the MDR and IVDR, clinical evaluations, declarations of conformity, risk analyses
Scientific content:
Clinical trials, research papers, findings, questionnaires, patient information leaflets
Marketing and software:
Product descriptions, marketing materials, software localisation, training materials
Trust delivers results.
Find out what our clients have to say about working with us.
"What really impresses us as a global company in our day-to-day work is the consistently high quality of the collaboration. AI translation using MTPE not only works well for us from a technical point of view, but also delivers reliable results when it comes to content. The connector between our CMS and oneTask, in particular, substantially enhances efficiency – so processes run stably and much more smoothly. It saves time and gives us peace of mind in our day-to-day operations."
Andre Korff
Head of Communication Concepts IAM, HELLA GmbH & Co. KGaA
"For over a decade, we have valued oneword as a reliable partner in a wide range of areas, including terminology and data management, machine translation and artificial intelligence, as well as a diverse range of translation and language services. For us, professional, trusting and mutually beneficial collaboration is the key to a stable partnership that delivers high-quality results."
Dr. Christopher Kurz
Head of Translation Management, ENERCON Global GmbH
"oneword has been working with us for many years now as an expert and reliable partner in translation management. Our collaboration is characterised by professionalism, commitment and high quality standards. We particularly value their technical expertise in project management, as well as their innovative strength and commitment to continuous improvement. Whether it’s AI, MTPE or international review processes, oneword delivers impressive solutions tailored to your needs."
Nikolina Čabraja
Manager Translation & Language Management, Phoenix Contact GmbH & Co. KG
"At oneword, you quickly get the feeling that you’re working with people who really know their stuff – both in the traditional language services sector as well as in the field of AI-supported translation processes. The team not only answers your technical questions, but also understands the context of the questions and meaningfully thinks through the implications. It’s at this intersection of language, technology and processes that their experience really shines through. This builds trust and makes working together a pleasant and productive experience."
Andre Korff
Head of Communication Concepts IAM, HELLA GmbH & Co. KGaA
"oneword is always a reliable partner for us. Projects are always handled promptly and competently, whilst always keeping our often challenging deadlines in mind. At oneword, every member of the team is always willing to listen to our needs and works with us to find the right solution through constructive dialogue. What I really appreciate about oneword is that translation jobs are always delivered on time, if not ahead of schedule. Thank you for your valuable cooperation."
Christian Derse
Team Lead Technical Writer, medion GmbH
"We have been working closely with oneword for several years now. We have no hesitation in approaching oneword even with complex requests, as they possess a high level of specialist expertise and the team keeps our specific requirements firmly in mind, providing comprehensive and purposeful advice. The excellent customer service is also particularly worth highlighting."
Lucia Laurer
Translation Management, implantcast GmbH
Why medical technology companies put their trust in oneword
Technical expertise
Our translators are not only language experts, they also have practical experience of the medical technology sector. Technical terms, standards and regulatory contexts are correctly contextualised – not merely translated.
Process reliability
Dedicated contact persons, a well-coordinated project management team and clearly defined quality processes ensure that your projects are completed on time and in a transparent manner – even with high volumes and tight deadlines.
Experience in medical technology
For many years, we have been working as a translation service provider with companies in the medical technology sector, delivering high-quality professional translations ranging from instructions for use to clinical assessments. You benefit from the fact that we are familiar with the typical requirements, timelines and documentation structures in your industry.
Regulatory expertise
MDR, IVDR, ISO 13485, IEC/IEEE 82079-1 – we incorporate your requirements into our translation processes. This ensures you receive translations that meet your quality standards.
Data security
We treat your documents confidentially – with regulated access rights, secure data transfer and clearly defined responsibilities within the project team.
Terminology management for technical translation
Consistent technical terms in all languages save time and money.
Technical translation with correct specialised terminology
Save time and costs with standardised documentation
FAQs
Do your translators specialise in medical technology domains?
Yes. We work exclusively with native-speaker professional translators who have proven expertise in the field of medical technology. Depending on the type of document, we select the appropriate specialisation profile.
How do you ensure the consistent use of terminology across multiple documents?
We work with client-specific terminology databases and translation memories. Your technical terms are defined and then used consistently across all documents and languages – including in subsequent updates.
How do you ensure that your translation outputs comply with the MDR and IVDR?
Our professional translators are familiar with the requirements of the MDR, IVDR and ISO 13485. The processes in accordance with ISO 17100 include translation, revision and a quality check carried out by specialist professionals – this ensures you receive documents that are reliable from a regulatory perspective and also comply with the requirements of IEC/IEEE 82079-1.
How much does translation in the field of medical technology cost?
The costs depend on the language combinations, the length of the document and the domain. We’ll draw up a bespoke quote for you based on the information you provide – just get in touch.
Professional translation for all your needs.
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