What’s New

  • Executive Brief: Translation and the EMA Centralized Procedure

    If you’re planning a submission to the EMA for a centralized procedure opinion, don’t forget to include translations in your timeline! With a strict submission deadline and 24 languages to source, you don’t want to wait until the last minute to coordinate with your translation provider. For a quick overview and some helpful tips, download […]

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  • Executive Brief: Translation and ISO 13485

    Working through an upgrade to ISO 13485:2016? Make sure that translations don’t fall through the gap analysis! Risk evaluation, quality agreements, and verification of product are all vital components to the new standard. But what do these mean for your translation process? We have put together some points to ponder. Check them out!

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  • Idem Upgrades Quality Management System to ISO 13485:2016

    We’re pleased to announce our upgraded certification to the 2016 revision of ISO 13485. Our quality management system is a vital part of our commitment not only to our medical device customers, but also to the patients, physicians, and regulators around the globe who read our translations. In addition to ISO 13485:2016, our quality management […]

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