There once was a time when medical device manufacturers asked themselves “why translate?” but the global markets and international regulatory requirements have altered this question to “How do we get it all translated?”
Medical device translations are intricate and require a high level of quality project management in order to produce documents that meet regulatory and user requirements, while also incorporating the quality and safety elements that are demanded in this field.
PREPARING FOR TRANSLATION
It is important that the following questions are asked and answered prior to beginning any translation work:
What needs translation?
How will country-specific regulatory requirements be handled?
Who will validate the translations once completed?
How will the translation process be managed?
SELECTING A TRANSLATION VENDOR
Manuals and other documentation are normally large projects and frequently multilingual. Case studies show that selecting a vendor to oversee the translation process is the most efficient. The following are requirements for a vendor:
They are able to provide translations in all of your target languages (piece mealing work to various language specific vendors diminishes the knowledge that is captured from one language to the next).
They can create a glossary of terminology for each language and use translation memory systems to create consistency for the long term. A good vendor knows how to use technology to create value in a very human-intensive process.
They have a focus and specialization in the field of medicine and in the life sciences industry. You should be sure that the people working on your translations are qualified in the therapeutic area of focus and that they understand the ways the device will be used.
They have a single contact coordinator who serves to manage the entire project and create consistency across languages. Nothing can reduce quality like turnover in project management. Having a reliable, stable translation vendor is crucial.
THE aiaTRANSLATIONS ADVANTAGE
Our team offers all of these components and also over two decades in the field of life sciences translation. We are a global, full-service provider of highly technical, medical-focused translation services.