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Medical Device Translation Service

Regulatory agencies require that all the documents and labeling for medical devices should be accurate as well as have clear and user-friendly language. The same applies to medical device translations.

Since the documentation typically includes information about the intended use, functionality, indications/contraindications, safety and other important features that can affect human health, choosing a translation company that is capable of handling all the pertaining complexities is crucial to succeed internationally.

After investing so much money, time and effort into development and registration, you need a provider which has everything it takes to ensure that your documentation remains both accurate and user-friendly in the target language.

Our Expertise in Medical Device Translation

With skilled linguists and robust processes, we provide high-quality translation services while meeting tight deadlines.

When it comes to products that are to be used by patients, the need for clarity and user-friendliness goes without saying. Still, medical device translation being user-friendly and unambiguous is essential for healthcare providers as well. Very often, doctors and nurses are required not only to be experts in their fields, but also to deal with rather sophisticated modern medical equipment. In line with your goals, we are committed to make the adoption as seamless as possible.

Usually, medical device documents are comprised of cross-subject texts ranging from medicine and electronics to software and computer systems. Our translation company engages best experts, many of whom are doctors or medical equipment engineers. This ensures accuracy and word choice conventional for medical community.

Here are some document types we translate:

  • Instructions for use
  • Labels
  • Operation procedures
  • Installation and maintenance guides
  • Safety documentation
  • Regulatory submission documents
  • Software UI and documentation
  • Manufacturing process descriptions
  • Declarations of conformity
  • Training resources
  • Marketing collateral
  • Data sheets

Meeting Regulatory Requirements

Medical device translation has to comply with various regulations and guidelines which depend on the market. For example, according to MEDDEV 2.5/5 rev.3 “the manufacturer should have procedures for ensuring accurate translation of e.g. labelling, instructions for use and product claims in marketing material”.

Our ISO 9001:2015 certified company can easily integrate our workflows with your quality management procedures. If you are still working on them, we would be happy to help and share our experience.

Furthermore, our expert linguists extensively rely on local industry standards, such as GOSTs, and other regulatory documents, which govern established terminology in the target language.

Since agencies like FDA define labeling as including accompanying materials, which extends even to advertising , the document package for translation may be quite large and heterogeneous. We will help you to ensure consistency in both terminology and style. Moreover, we can engage experts in additional subject fields since our translation company also specializes in such domains as medicine, pharma, legal and insurance.

Medical Device Localization

Our company provides professional localization services. We have extensive experience in the field and rely on the industry’s best practices. For medical device localization we ensure that UI is both accurate and easy to understand, while keeping the string length as short as possible.

Processes and Technology

Rigorous processes and workflows adopted by our company further ensure consistent quality. Various procedures of quality control eliminate the possibility of human error. Following industry standards and best practices, we deliver professional translations for every order – be it a large set of documents or just one word.

A dedicated project manager will see that all your needs and requirements are taken into account. If you have some reference materials and need the translation to match them – from a word on a label to a chapter in an IFU – we will keep consistency with what was translated before.

We know that in some cases time is key. You may be sure that your medical device translation will be delivered on time, even when the deadline is tight.

With state-of-the-art technology, we can offer ultimate quality combined with cost efficiency. Translation memories and term bases in CAT tools ensure:

  • Consistency between documents and projects to avoid even minor differences
  • Approved terms use to guarantee that a correct terminology is maintained throughout the project
  • Easy on-boarding of new team members to provide for project team scalability
  • Leveraging existing translations to save time and money

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