In this post, I am not going to provide details regarding the directives which govern when you need to translate medical device documentation. If you reached this post, chances are that you need to translate your medical device documents into other languages. This can be due to regulatory demands or due to market requirements. Either way, you find yourself with the need to provide translated medical device documents. This post will try to sort out some good practices as you go about this task.
What kind of medical device documents and texts will you need to translate?
There are several types of documents that you may need to translate when distributing a medical device in another country. This includes:
- Regulatory Compliance Documents
- Instructions for Use (IFU), also referred to as Directions for Use (DFU). These can be short 1-2 documents for simple devices; they can also be 100-200 pages long for more complex devices like imaging scanners.
- Physician Manuals
- Medical device software interface. This can be custom medical device display screens or software which runs on a standard operating system like Windows. You will need to provide the translation company with the software resource files for localization.
- Product packaging and inserts
- Investigator’s Brochure (IB). “The IB is a compilation of the clinical and nonclinical data on the investigational products that are relevant to the study of the product (from University of Pennsylvania Medical School.
- Case Report Form (CRF). This is a document that records the patient information, as required by the study protocol, which must be reported to the sponsor of the clinical trial.
- Informed Consent Form (ICF) when the medical device needs to be tried on human patients prior to being approved for use.
- Training material used to train the medical staff using the device.
Determine Regulatory Requirements in Advance
Find out which documents and papers you need to translate. Determine which language variants are required. Check medical device product labelling requirements Also check if there are any special quality standards required in the translation process such as back translation and certification. Getting this information in advance will ensure that you get the job done right the first time. It will also help to avoid reworking the translations or translating more documents than was initially planned.
Maintain Translation Memories
Medical device documents, especially IFUs, tend to be revised frequently. That’s why you need a translation memory, or TM. A TM is a file that translators use to reuse legacy translations. That way, if the revised IFU only changes a few paragraphs you will only need to translate the new stuff while leaving the old text as-is. This will not only save you money, it will ensure that revisions get done faster. The most common format of TM files is the TMX format. Ask your translation vendor for the TM when the job is delivered. That will enable you to get cheaper quotes on subsequent translation projects.
Find the Winning Design
Many medical device manufacturers publish IFUs in as many as 20 languages. They often combine all of the languages into one publication. Cramming many languages into one publication can be challenging but not to someone who knows what they are doing. Work with a suitably experienced designer who will put your IFU together. Make sure that the translation agency can provide the texts in a format which will allow seamless integration into the multi-language IFU.
Translate the Software UX First
If you are localizing the medical device interface into other languages, do this first-before translating the IFU and the other documents. Integrate the UX translations into the translation memory. This will allow you to use the UX translations consistently in the documentation. It will also allow you to replace screenshots with translated versions.
Make the Graphics Editable
Any graphics that depicts operation sequences, assembly/disassembly, maintenance of parts and such should be editable. If there are texts inside the graphics, make sure that the translation company can edit the graphics. Otherwise it will require extra work and expense to localize the graphics.
Use Standard Labelling Translations
Every medical device IFU contains a list of symbols which classify the hazards and other general usage information related with the device. Each symbol has standard wording which is contained in the relevant directives. It is recommended that you use standard language when translating the IFU and not reinvent the wheel. Translations for most labels can be found on official websites provided by the relevant authorities like the European Union (EU).
About the Author
David Grunwald is the Managing Director of GTS Translation Services, a leading professional translation company. GTS specializes in medical translation services for leading medical device manufacturers. GTS has translated hundreds of IFUs and medical device documents into over 30 languages.