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:
- Regulatory | CE marking
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.
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
- Clinical study results
- Informed consent forms
In addition to medical device translation and localisation, Novalins also offers the following services:
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.