A medical device is an instrument which is used to diagnose or treat a medical disease or condition. Opposite to a drug, which causes a chemical action, a medical instrument acts by physical or mechanical means.
Medical devices cover a wide range of instruments from very simple i.e. thermometer to complex devices like stents, pacemakers, and other medical imaging systems. The production, sale, and supply of these devices are regulated in many countries of the world. Medical device manufacturers maintain the regulatory departments to verify the compliance in the countries. As the regulation of devices varies from one country to other, so this is an onerous duty. The regulatory affairs manager of the company is responsible for keeping the record of the changes occurred and guides the company in its compliance.
Translation services play an important role in assembling the regulatory directives around the world. Generally, medical devices documentation and labeling should be available in the official language of the respective country. In the European Union, there are about 20 member states with almost 20 languages. Content that requires translation includes Instructions for Use, medical device labels, User Interface, marketing material, packaging, and other technical content. Medical Device Company that sells its product all over the world needs to translate their material in almost 25 different languages.
These companies sometimes outsource their translation work to translation industry that is specialized in offering translation services in the medical field. These agencies will specialize in the field and have wide experience in translation of such devices. There are some issues to consider while managing the language requirements when companies sell their medical devices.
Instructions for Use: These are also called Directions for Use. These documents may consist of 1-2 pages in case of simple medical devices and over hundred pages for complex one. The document is basically a product manual containing the instructions for using the device. These are printed in many languages in a common printed document and the languages identifier is also placed to identify the language.
Marketing Material: These materials include brochures, roll ups, data sheets, graphic emails, and web content. Some also contain high-resolution graphics and photos. Apart from content translation, marketing material sometimes needs page layout in some DTP applications like Illustrator or InDesign. Make sure that medical translation company keeps the required layout software and provide translated material in several languages and on time.
Training Material: After approval of a medical device in a particular country, local personnel (doctors, nurses, hospital staff) requires training on the use of that medical device. Training material is made available on PowerPoint. The material also required to be translated into the PowerPoint file to comply page layout issues.
Software Localization: Some devices are software driven along with its interface that navigates the user throughout the operation. Software Localization of UI is required in some countries. This process includes translation of resource files, testing of these files after translation and finally insertion of screen shots in the manuals, marketing material, and IFU.
Accuracy Certificate: Regulatory directives require the medical device company to issue a certificate of accuracy with translations. Make sure that your company is offering this service with the translated document.