How to Prepare Your Content for Medical Device Translation

 

In the medical device industry, it is regulatory requirement that information accompanying device must be in the language that is possible to be understood by user and or care giver usually doctor. So, translating is not a choice.

It is essential that translation is not just colloquial language and slight variation is also an issue, Medical terminology must be unique and specific to that region or country.

Since this being very important subject and compliance is on high agenda, most industry prefer professional translator who are recognised by regional or central government agencies.

Some factors contributing to the challenging task of medical device translation are:

If we understand the complexities of translation, then only real work result will come. Translation here does not just mean verbatim translation. Look at following essential points.

·         Medical terminology / lexical and colloquial differences between languages for Example in India national language uses the word “Nasta” (snacks) irrespective of time while the difference is clearly specified in English language like break-fast and snacks. Timings are important so break-fast cannot be translated as “Nashta” but must be specified with time like morning, evening.

·         Regulatory requirements for medical device labelling by region and country

·         Sheer volume of content to be translated for medical devices. This is substantial volume considering all material like IFU, Label, other regional requirement.

·         Ongoing device improvements and periodic regulatory changes these brings changes in text matter so also its translation.

·         Medical device packaging updates.

Preparation and Planning for Medical Device Translation.

In fact, this should be part and partial of any project for any new medical device launch.

Following steps may be useful for translation part.

1.       Gather all the items list which may need translation.

2.       Be prepared for text expansion, please note that translation will not be just verbatim and actual regional language translation to convey very close to accurate message as original which may need text expansion.

3.       Keep auditable source file so any time expert can have view and use it if needed.

4.       Since many such translation will be needed for many products and many of words will be used again and again so it is beneficial to prepare glossary for product.

Select and keep ready medical device professional translator information. It is not only user faced material need to be translated but even product related material also need translation as many regulators of specific region will need this.

5.      Sometime regulation of specific region need only some changes related to that region.

6.      Legal requirement of translation for specific region or country also need attention.

Often, medical device OEMs are using an internationally recognized set of symbols to speak important information within the place of words. Sources like the ISO 15223-1:2016 standard list symbols used for a good array of medical devices in many countries.

This is an attempt to supply consistency and stop errors in translation which will seriously harm patients or caregivers. It also reduces the quantity of text requiring translation and therefore the resulting text expansion, speeding the method by standardizing layouts for documents and labels.

Also, as medical devices and technologies evolve, the accompanying software and documentation must be revised altogether the previously translated languages. Manufacturers retain liability for his or her devices throughout the product’s lifespan, including any upgrades or mandated regulatory changes.

Since this is continuous and part of business process it is advisable to have professional translation service provider who is an expert in all aspects of medical device translation requirement.

Impact of wrong or ambiguous translation is very risky for company and its reputation and business.