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Selecting the right linguists to translate life science content is a critical process due to the specialized nature of the field and the fact that the market is highly regulated. Documents may comprise a mixture of complex scientific data, medical terminology, and technical language. Inaccurate translations in clinical trial documentation, patient information leaflets, or drug labels can jeopardize patient safety, leading to the improper use of medication or devices. It is vital to ensure accuracy, compliance, cultural sensitivity, and clear communication, all of which are essential for the safety, effectiveness, and success of life science products and services.

The implementation of the new MDR has introduced several new changes and requirements regarding the labeling and usage instructions for medical devices. These modifications impact the content that requires translation. Specifically, the MDR underscores the importance of providing clear and understandable information to users, encompassing patients, healthcare professionals, and even software UI now recognized as part of product labeling. The classification of software has undergone drastic changes under the EU MDR and IVDR, resulting in virtually no medical device software falling under low-risk categories (unlike the situation under the MDD). The updated language requirements for software are expected to influence manufacturers’ software translation/localization policies, prompting a more rigorous examination of the translated UI.