Labeling translation is a necessity for all medical device companies looking to produce, market and distribute their products on a global scale.
The earlier you introduce localization best practices into your process, the easier your path will be to achieving your final result. So if you’re a labeling specialist or otherwise responsible for managing all components of the process, what exactly do you need to know about medical device labeling translation?
Think about your end goals and how to achieve them
Consider some ways in which you can create an efficient process that stresses making labeling materials ready to go and fully optimized for localization. The final result should be easy to read and navigate, and easy to understand. After all, the literature that supports the medical devices you produce serve as a bridge to effective use; ultimately it impacts a person’s quality of life. And of course, these days there are the ever-present legal consequences of translation mistakes to consider. For a prudent, timely and cost-effective outcome, think about how you can positively impact and streamline labeling translation right out of the gate.
Start with high-quality source documents
Imagine as a global user that you’ve received a 200-page document that includes references to pieces of external information that you’d have to look up. This may not be the most user-friendly document in the world. If readers skip sections or bypass reading it altogether, the whole purpose is undermined. A much better solution is to cull the vital information into a concise and clear, information-critical document that’s easy to navigate. Doing this means less to translate, a faster time to market and lower costs to boot.
The stakes are high, so whatever material is to be translated—from instructions for use (IFUs) to warning labels—begin taking steps toward developing a universally followed process ensuring that all of the components are created in standardized and consistent ways. You may already be doing this; and if so, you’re on the right track. Going further, ask yourself what content surrounding your medical device labeling translation project requires localization, and usher each piece of content through the translation lifecycle in a consistent fashion.
Also think about incorporating preapproved terminology (such as from your glossary and style guide) into your source content—this action alone can be invaluable. Be sure your content authors are authoring source documents with language translation in mind, which will result in a much easier time for everyone involved in the translation lifecycle!
Know your target languages and their requirements
At the beginning of every labeling translation project, be sure that you know which target languages you’ll be translating into. Consider each language’s particular requirements regarding the amount of space the translated text will occupy and any possible text expansion. This will give you a firm idea of how to prepare the container and layout so that they can accommodate your translated text. Why does this matter? Well, if a medical device label needs to include seven languages, but it’s far too small—that definitely presents a challenge.
For some medical device products in certain countries, there must be an e-labeling component as well. Think and plan for this possibility ahead of time.
Seek complete quality management driven by industry standards
When partnering with a translation provider for medical device labeling translation, it’s in your best interest to make sure they follow a robust quality assurance management system. One part of that will mean that their quality process is driven by industry standards and certifications. This may include certifications relevant to your industry such as ISO 9001 and ISO 13485, among others. Your provider should demonstrate to you how they conform to the industry regulations and standards that you must follow as well.
In short, a translation provider like YBD is held accountable to our quality assurance management system, which for you means reliable high quality and more peace of mind.
Whether you’re a newcomer to medical device labeling translation or this isn’t your first time at the rodeo, let us know what you think. Would you add any other guidelines to this post?