What is a disposable? What does Class I, Class IIa, IIb and III have to do with medical devices? Or why can’t a verb meaning “transmission in the air” be used to say “transmission of sound waves”?
All these questions may seem quite obvious to those specialists who work in this domain, and it is of the utmost importance that your translator knows the reason behind the word you use, so he can convey the right meaning when providing translation of documents used in the medical domain.
Very few areas require the same attention to detail as that of medical devices, which are central to human life and healthcare, and strictly related to different technologies such as biomedical sciences, ICT and nano-technologies.
Nowadays, medical devices represent a complex and highly segmented market. According to the MHRA, there are over 200,000 pieces, of which 10,000 are commercialized in Europe, and it is thus a complex and varied market involving legal texts and ISO, EN and UNI regulations.
Biomedical translations are needed in quite a wide variety of contexts
- Translation of technical documents of medical devices
- Translation of test report
- Translation of Declaration of Conformity of medical devices and medical equipment
- Translation of clinical investigation documents
- Translation of documents required to obtain CEM (Medical Devices Classification) conformity to type Certificate of Registration
- Translation of medical devices brochure, user guides and catalogue
- Translation of legal documents used in court proceedings involving medical aspects of any sorts (medical error, negligence, tort, compensation of damages, etc.)