Sample documents for translation

Instructions for use of medical devices
software used for medical purposes
Material Safety Data Sheets
labelling of a medical device
descriptions of manufacturing technologies, project drawings, details on studies, tests and other aspects of validation
risk analysis reports

list of the harmonised standards applied
results of project calculations and test results, including those related to compatibility with other devices
clinical assessment results
description of sterilisation methods applied
labels and instructions for use
declarations of conformity
promotional materials

Compliance with the regulations valid in the medical device industry

In May 2021 the EU Medical Devices Regulation (MDR) (2017/745/EU) came into effect and replaced the previous Medical Devices Directive (MDD) (93/42/EEC). Regulations on in vitro diagnostic medical devices 98/79/EC (IVDD) have been changed as well, with the more detailed regulation IVDR 2017/746/EU. A new requirement in the regulations is, among others, to share the translated IFU (Instructions For Use) on the manufacturer's website and in the EUDAMED EU database of medical devices. Along with the instructions for use, the following, among others, should be provided as well: information that can be used to determine when a product should not be used any more, details, warnings or precautions to be taken to facilitate safe disposal of the device, and a warning to bring the user’s attention to the need to report a situation when a serious incident occurs in relation to the device.

Translations of the instructions for use

Correct translation of the instructions for use requires that the translator has both medical and technical knowledge in order to be able to understand how certain medical equipment works. At Omero, we know that it is also necessary to have excellent knowledge of the source and target language at the native speaker level in order to adapt the text to the recipient and conduct appropriate localization of the content. Our translation project managers select the appropriate translator who is able to adapt the translation to the user depending on their technical knowledge and experience (instructions for use of devices intended for doctors or patients).

Certification of translations

Translations of medical device documentation are performed both for entities operating on the EU market and for entities outside the EEA countries acting through their authorized representatives. All materials provided to us are subject to strict confidentiality and information security procedures, which is confirmed by the ISO 27001:2017 standard certificate that we hold. Translations are performed based on the ISO 17100:2015 standard and the quality of translations is confirmed by the Certification of Translation Accuracy.

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