by David Grunwald
A medical device is an instrument, device or implant which is used to treat or diagnose a medical condition or disease. As opposed to a drug, which induces a chemical action, a medical device acts by mechanical or physical means. Medical devices range from simple devices like thermometers and blood pressure monitors to advanced devices like pacemakers, stents and medical imaging systems.
The development, sale and distribution of medical devices are strictly regulated in most of the countries in the world. This requires medical device manufacturers to maintain regulatory affairs departments in order to verify compliance in all countries of sale. This is an onerous task, as the regulations vary from country to country and are also subject to frequent changes. Indeed the Regulatory Affairs manager in a medical device company needs to keep abreast of all the changes in the directives and guide the company accordingly in its compliance objectives.
Translation services play a huge part in meeting the regulatory directives in the various countries. In general, medical device documentation and labeling must be available in the official languages of each country. In the European Union alone there are over 20 different member states and over 20 languages. Materials that require translation include the medical device labels, Instructions for Use (IFU), packaging, user interface (UI), marketing materials and other technical information. Medical device companies that sell their produce worldwide may need to translate these materials in as many as 25 different languages.
Medical device companies usually outsource this translation work to translation companies that specialize in translation services for medical devices. These translation agencies will specialize in medical translation services and have extensive experience in translation for medical devices. Here are some issues to consider when reviewing the language requirements for sale of medical devices.
Marketing Materials. These can include roll-ups for trade show booths, brochures, graphic emails, data sheets and web content. Some of the marketing materials contain hi-resolution photos and graphics. Aside from the translation of content, marketing materials often require page layout in DTP applications like InDesign or Illustrator. Make sure that the medical device translation company has the required page layout software and can provide fast delivery of marketing materials in several languages at the same time. These materials are always needed urgently.
Instructions for Use (IFU). Also referred to as Directions for Use (DFU).These documents can range from 1-2 pages for simple medical devices to over a hundred pages for complex devices. These are basically product manuals that provide instructions on how to use the device. IFUs also contain standard caution and warning labels that pertain to the use of the device. IFUs are often printed in several languages in the same printed document, with language identifiers on each page to indicate each language. The translation vendor should have the capability of combining all languages in the IFU page layout.
Clinical Training Materials. Once a medical device is approved for use in a specific country, local personnel (such as hospital staff, doctors and nurses) often require training on the use of the medical device. Clinical training materials are often made available on PowerPoint presentations. These materials need to be translated with the PPT files adjusted for page layout issues (such as text expansion).
Medical Device Software Localization. Some medical devices are software-driven, with a User Interface (UI) that navigates the user through operation. Some medical devices have custom LCD displays, while others use standard operating systems like Windows or iOS. Localization of the UI is often required in various countries. This work entails translation of software resource files, linguistic testing of the files after translation and insertion of screen shots into the IFU, manuals and marketing materials.
Certificate of Accuracy. Regulatory directives may require the medical device company to file a translation Certificate of Accuracy with each translation. Make sure that your translation company offers this service.
Translation Memory and Terminology Management. Ask your translation vendor to use translation memory (TM) software tools when translating medical device materials of all kinds. Medical device documents, especially IFUs, are updated frequently. Using a TM will save costs when updating or revising the texts. Additionally, there is a certain amount of repetition between the various texts (for example, clinical training materials may use text from the IFU) and use of TMs will save time and money. Verify that the TM is associated with a terminology management application to ensure consistent use over time of terminology throughout the translated texts.