The rapid globalisation of the medical devices industry presents considerable opportunities for manufacturers. It has never been easier to access international markets and achieve growth on a worldwide scale. However, this strictly regulated market brings its own challenges. Accurately translated documentation is absolutely vital to the safe and effective operation of medical devices. When even minor mistakes can leave manufacturers vulnerable to litigation, and possibly endanger lives, there is simply no room for error. Accordingly, manufacturers are expected to adhere to the most stringent of quality standards when marketing equipment for international use. Our clients tell us that we provide the best medical device translation service they have encountered.
International regulatory bodies require that vendors, medical professionals and end-users in the country of use can understand device documentation with perfect clarity. Careful consideration must be given not only to the accurate translation of documents into the local language, but also to the localisation of documents to account for cultural differences. In short, a comprehensive medical device translation solution is required.
Our services in this field
Medtrans has a large team of certified NAATI translators and editors with extensive professional experience of the medical devices industry. We have translated a vast range of documents in this area, including user manuals and patents. As a medical device translation specialist, we have a narrow focus and deep expertise.
Documents we commonly translate:
- User manuals
- Directions for use
- Packaging and inserts
- Technical specifications
- Software application interfaces
- Maintenance instructions
- Case report forms (CFO)
- Informed consent forms (ICF)
- Regulatory compliance documents
- Marketing materials
- Clinical research data protocols
- Clinical study documentation
In addition to our translation services, we offer proofreading, back-translations, editing/laying out, transcription and data entry. Our capable team is always happy to take on new challenges, and our capacity ensures that we can usually accommodate new and challenging projects.
All of our medical device translators are accredited by the National Accreditation Authority for Translators and Interpreters (NAATI) as a minimum standard, and we can also provide US- and EU-accredited translators as needed. We work in over 130 different languages and dialects, covering all major medical and clinical device markets. Translators work in their native language and are conversant with all related medical terminology in both the origin and the source language.
Once it has been translated and proofread by a medical device translation expert, the work is meticulously inspected to assure technical, linguistic and cultural accuracy, and compliance with all relevant regulations. You can also opt to have your documents further proofread by one or two independent, native-speaking editors with expertise in the medical devices field. You also have the option of typesetting to ensure your document looks professional and publication-ready.
We appreciate the sensitive nature of medical devices documentation, and have measures in place to ensure strict compliance. All our medical devices translators are subject to binding non-disclosure agreements. We can also sign additional confidentiality agreements when required.
Contact us now for a free quote on your medical devices translation project.
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Medtrans is a provider of medical translation solutions
in Australia with 10 years of translation experience.