Translation programs used in Medical Device Quality Management Systems (QMS) documents are of great importance, especially for labels, user manuals and other important documents. Accurate and reliable translation of such documents is critical for meeting legal requirements and ensuring customer satisfaction. But how are these translations done and then validated? In this article, we will discuss the validation process of translation programs step by step.
Translation programs offer fast and efficient translations thanks to AI-powered translation engines. However, the accuracy and reliability of these translations are of paramount importance, especially in the medical device, pharmaceutical or other industries with regulatory requirements. Therefore, there are some critical points to be considered during the selection and use of translation programs:
– Literature Studies: Scientific literature studies can be used to evaluate the accuracy of translation programs. For example, academic articles comparing different translation programs can show which program produces more accurate results. Such studies are an important source for objectively evaluating the performance of translation programs.
– Translation Verification: Translations produced by translation programs should always be subjected to human verification. In particular, it is important to have the translation verified by a native speaker of the target language to ensure the integrity of the meaning of the translation in the target language. In addition, an English speaker can also check the alignment of the translation with the source text.
Translation validation is a process to verify that translation programs are suitable and reliable for their intended use. This process is conducted in accordance with the requirements of standards such as ISO 13485:2016 and ISO/TR 80002-2:2017. Here are the basic steps of the translation validation process:
2.1. Installation Qualification (IQ)
Translation programs usually do not require installation as they are web-based. However, if installation of the program is required, this stage verifies that the program is correctly installed and operational.
2.2. Operational and Performance Qualification (OQ & PQ)
Operational qualification is performed to verify that the translation program operates within established process control limits. Performance qualification aims to verify that the program produces consistent and acceptable results under normal operating conditions. At this stage, the accuracy and reliability of the translation program is supported by literature studies and client approval.
2.3. Risk Control Strategy
Risks that may arise during the translation process are analyzed in accordance with ISO 14971:2020. For example, the risk of mistranslation in Medical Device documents can compromise the integrity of the meaning of the translation in the target language, which can lead to serious consequences. To minimize this risk, translations should always be verified by a native speaker of the target language.
The final stage of the translation process is the approval of the translation by the client. In particular, a customer representative who is a native speaker of the language of the country to which the translation will be sent, or a surgeon who actively uses medical devices, confirms the accuracy of the translation. This step is crucial to prevent translation errors and ensure customer satisfaction.
In case of any changes in the translation process (e.g. updating the translation program or adding a new language), the validation process should be repeated. This ensures that translations remain consistently accurate and reliable.
Validation of translation programs used in QMS documents is a vital process to ensure the accuracy and reliability of translations. Steps such as literature studies, translation verification and customer approval form the basis of this process. A proper validation process minimizes the risk of inaccurate translations and increases customer satisfaction.
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