24 Feb What is medical software translation?

In most cases, medical software will be considered a medical device in itself and as such must be subject to the same regulations as medical devices. Therefore, according to Directive 2007/47/EC, if the software is classified as a medical device, the language requirements included in MDD 93/42/EEC apply. So the translation of medical software is more than necessary.

What is translated for medical software?

For medical software, the instructions for use must be translated. Thus, the translation of medical software will include documentation such as instructions for use, user manuals, installation, packaging and labelling manuals. In addition, for software classified as a medical device according to Directive 2007/47/EC, ‘indications’ would include the graphical user interface (GUI), menus, dialogue boxes, error and status messages, on-screen help, etc.

However, some medical device manufacturers will try to argue that the users of the software know languages other than the official language of the country in which their product is marketed. This excuse cannot be considered valid in any way since there is no credible way to argue that each and every user of such software knows the language in which it is presented well enough to eliminate any risk to their own or their patients’ health.

At Okomeds we specialise in the translation of medical software. Our professional medical translators will take care of your medical software translation needs. Shall we talk?