Medical and pharmaceutical industry

Your medical and pharmaceutical language service provider

ISO 17100 certified processes, guaranteed quality

ISO 17100 certified, we provide translation services that meet the specific requirements of the medical and pharmaceutical world. Depending on the requirements of the quality control bodies that concern you, we adapt this translation process by integrating one or more levels of proofreading by linguistic experts in order to guarantee an optimal level of quality.

A responsive team and respected deadlines

Aware of the timetable imposed by regulatory authorities and their requirements in terms of translation quality, we dedicate experts within our teams to accompany you from the definition of your requirements to the delivery of the translations within the given deadline.

Formatted, ready-to-use content

Whether you need IFU, PIL, or packaging, our graphic designers will create or integrate the layout of your content once it has been translated. You no longer need to take care of this step yourself, we make sure that the original design of your documents is respected even in your international markets.

Continuously optimized projects with the help of translation memory

As a result of our experience, we have noticed that a large part of the content is repetitive. In order to capitalize on your past translations, we offer you a system for recording your translations in the form of databases; this is the translation memory.

For your most repetitive content (IFU, marketing authorizations, etc.), the gain can quickly reach 40% optimization per language. Thanks to our technological tools, we create your own translation memories, ensure transparent terminology management, and archive all your multilingual documents.

Certified processes and rigorous quality controls

The quality of the contents is undoubtedly your N°1 concern if you are an actor in this field. The slightest error or misinterpretation can have serious consequences for you and your customers. Aware of these stakes, our quality control processes are closely monitored and corrective and preventive actions are regularly implemented.

In addition to the controls carried out on projects, we regularly test and re-evaluate the level of our translators so that we can re-train them if necessary.

ISO 17100 certified since 2015, the selection process of our resources as well as the follow-up of our projects are done in compliance with this standard and are subject to an annual audit which guarantees the quality of our processes and the respect of the good practices implemented.

Medical translations in Europe

Although there are many similarities in the translation requirements, it is the European regulation that is authoritative for medical devices and must be followed by all member countries. Three directives regulate the sale of medical devices in the European Union and the translation requirements for these products:

93/42/EEC concerning medical devices
90/385/EEC on active implantable medical devices
98/79/EEC on in vitro diagnostic medical devices - This directive covers devices used to analyze tissue, blood and other fluids.

EU directives classify medical devices according to their ability to harm patients, users or people in their surroundings.

Class I devices: low risk devices
Class II A and II B devices: medium risk devices
Class III devices: high risk devices

The translation requirements are therefore also dependent on the classification. The higher risk devices in classes II and III as well as most class I devices require certification by a third party and an EU certified representative.

In order to comply with these European directives, rely on our team of expert health translators, trained in these regulations, to assist you with the complete translation of your content into all EU languages.