Specialization

Novalins specialises in the translation and localisation of medical and surgical device documents, and helps to ensure that the translated documents follow international and national standards – technically, linguistically and culturally.

Novalins specialises in the following medical device translation fields:

  • Engineering
  • Clinical
  • Regulatory | CE marking
  • Marketing
  • Training
  • Corporate

Experts

Novalins has a strong team of professional medical translators and editors who specialise in medical device translation in over 120 languages.

Our medical translators, editors and writers are carefully selected on a project basis according to their linguistic and technical skills, experience in the area of specialisation, as well as their knowledge of regulatory requirements in the Americas, Europe and Asia. All experts allocated to every medical device translation project meet a minimum criteria:

  • Certified medical translators by recognised bodies
  • Proven experience in medical device translation
  • Working in their native language, with perfect command of the source language
  • Access to medical terminology databases and dictionaries (e.g. DIN EN 980:2008-08, DIN 6877-1:2007-12)

Novalins offers our clients full transparency on the experience and qualifications of the medical translators, editors and medical writers who work on their projects.

Documents

The most frequently translated medical device documents include:

  • Instructions for use (IFUs)
  • Directions for use (DFUs)
  • Packaging inserts and Labelling
  • Product manuals
  • Case report forms
  • Data protocols from clinical research/li>
  • Clinical study results
  • Informed consent forms

Services

In addition to medical device translation and localisation, Novalins also offers the following services:

Confidentiality

Novalins understands the sensitivity of medical device documents and all our medical translators and experts work under binding non-disclosure agreements. We are also open to any additional confidentiality arrangements requested by our clients.

Our medical device translations include the following quality steps:

  • 01

    Translation by a senior medical translator, native speaker of the target language with perfect command of the source language and specialization in the subject matter

  • 02

    Proofreading/editing by a second equally qualified translator with subject matter expertise and significant experience with translation for clinical research and clinical trials.

  • 03

    Non-linguistic accuracy review by an additional reviewer

  • 04

    Final review by a Novalins project manager specialized in medical translation.

  • 05

    Certificate of Accuracy detailing the quality steps taken as well as the qualifications of the translation team that worked on your project.

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