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. We can adjust our translation process in accordance with the requirements of the quality-control standards that concern you. This is done by integrating one or more levels of proofreading carried out by language experts, guaranteeing optimal levels of quality.

A responsive team and respected deadlines

We're aware of the timetable that regulatory authorities have imposed on you, and their requirements in terms of translation quality. That's why we dedicate experts within our teams to accompany you through every stage of your project, from the definition of your requirements to the delivery of the translations within the given deadline.

Formatted, ready-to-use content

Whether you have IFUs, PILs, or packaging, our graphic designers will create or integrate the layout of your content once it has been translated. So, relax! You no longer need to take care of this step yourself. We make sure that the original design of your documents is preserved in every language.

Continuously optimized projects with the help of translation memory

A considerable amount of medical and pharmaceutical content is repetitive. Capitalize on your past translations by relying on our translation memory system, which records your translations in database form.

For your most repetitive content such as IFU, marketing authorizations, etc., optimization levels can quickly reach 40% per language. With our technological tools, we create your very own translation memories, ensure transparent terminology management, and archive all your multilingual documents.

CERTIFIED PROCESSES AND RIGOROUS QUALITY CONTROL

As a participant in the medical field, the quality of your content is undoubtedly your top concern. The slightest error or misinterpretation can have serious consequences for you and your customers. At Powerling, we know what's at stake for you. Accordingly, we closely monitor our quality control processes and regularly implement corrective and preventive actions.

In addition to our quality assurance measures for your projects, we regularly test and reevaluate the performance of our translators so that we can retrain them when necessary.

Powerling has been ISO 17100 certified since 2015. Our practices are in conformance with ISO standards and are audited annually. Such practices include the selection process for our resources as well as our procedures for following up on projects. Our adherence to ISO standards guarantees the quality of our practices and their consistent application.

Medical translations for Europe

Although there are many similarities in translation requirements internationally, all European Union member countries are bound by a specific set of authoritative medical device regulations. Three directives regulate the sale of medical devices in the European Union and the translation requirements for these products:

93/42/EEC: medical devices
90/385/EEC: active implantable medical devices (AIMDs)
98/79/EEC: in vitro diagnostic medical devices (IVDs), covering devices used to analyze tissue, blood, and other fluids.

EU directives classify medical devices according to their potential capacity for causing harm to 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

For this reason, translation requirements are also dependent on classification. The higher-risk devices in Class II and Class III, as well as most Class I devices, require certification by a third party and an EU-certified representative.

When your content has to comply with these European directives, we can make sure that it does. Our team of expert life-science translators, who are well-versed in these regulations, can translate all your content into all EU languages.