At Language Scientific, we specialize in providing precise and culturally sensitive translations for the in-vitro diagnostic (IVD) industry, ensuring compliance with international regulations and effective global communication.
Regulatory Compliance: We deliver translations that meet the stringent requirements of the European Union’s In-Vitro Diagnostic Regulation (IVDR), facilitating smooth market entry and adherence to local laws.
Expert Linguists: Our team comprises professionals with deep expertise in medical device terminology and language intricacies, ensuring accurate and contextually appropriate translations.
Quality Assurance: Our ISO 9001:2015 and ISO 17100:2015 certified quality management system guarantees high-quality translations that address specific linguistic and cultural nuances of each target market.
Comprehensive Document Support: We handle a wide range of IVD-related documents, including user manuals, product labels, clinical reports, and regulatory submissions, ensuring all materials are accurately translated and culturally adapted.
Ensuring compliance with the European Union’s In-Vitro Diagnostic Regulation (IVDR) is crucial for medical device companies operating within EU markets. A key component of this compliance involves adhering to specific language translation requirements.
Mandatory Translations: All information accompanying in-vitro diagnostic devices, including labeling instructions and Instructions for Use (IFUs), must be translated into the official EU languages of the countries where the device is marketed.
EU Declaration of Conformity: This declaration must be translated into the official languages required by each EU member state where the device is available.
Field Corrective Actions: Documentation related to corrective actions must be translated into the official languages of the countries where the device is distributed.
Importance of Compliance:
Patient Safety: Providing clear and accurate information in the local language ensures proper device usage and enhances patient safety.
Regulatory Approval: Meeting language requirements is a critical step in obtaining and maintaining market access within the EU.
Ensuring compliance with the European Union’s Medical Device Regulation (MDR) is essential for medical device companies aiming to market their products within EU member states. A critical aspect of this compliance involves adhering to specific language translation requirements.
Mandatory Translations: All information accompanying medical devices—including labels, instructions for use (IFUs), and marketing materials—must be translated into the official languages of each EU member state where the device is marketed.
Regulatory Documentation: Documents such as the EU Declaration of Conformity and technical files must be available in the required languages of the respective countries to facilitate regulatory reviews and approvals.
Patient Safety Information: Critical safety information and clinical data intended for patients and healthcare professionals must be accurately translated to ensure proper understanding and usage of the medical device.
Importance of Compliance:
Regulatory Approval: Meeting language obligations is a prerequisite for obtaining and maintaining market access within the EU.
Patient Safety: Providing clear and accurate information in the local language ensures proper device usage, thereby enhancing patient safety and reducing the risk of errors.
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Accurate translation ensures regulatory compliance, patient safety, and proper device usage. Errors in translation can lead to misuse, safety risks, and regulatory rejections by agencies like the FDA, EMA, and MDR authorities.
Medical device translations cover a wide range of materials, including:
We use AI-optimized workflows combined with subject-matter expert linguists, rigorous quality control, and back translation when required. Our process follows ISO 17100:2015 and ISO 9001:2015 standards for medical translations.
Yes! We specialize in medical device software localization, including user interface (UI), eLearning modules, and multilingual voiceovers. We ensure translated content aligns with technical requirements and regulatory standards.
Turnaround time depends on document complexity, language pairs, and regulatory requirements. However, our AI-optimized translation process ensures fast, high-quality results without compromising accuracy.
Yes! We provide multilingual translation services for over 215 languages, ensuring global market access while maintaining technical precision and compliance.
Back translation is the process of translating a document back into its original language to verify accuracy. It is often required for regulatory approval and quality assurance in medical device documentation.
Yes! We provide certified translations with Certificates of Translation Accuracy (COTA) to meet regulatory requirements for medical device approvals.
We follow strict data security protocols, including NDAs, GDPR compliance, HIPAA regulations, and secure file transfers, ensuring full confidentiality of sensitive medical device information. Our technology management system is ISO 27001 certified.
Language Scientific offers expedited services for urgent projects while maintaining our commitment to quality and accuracy. We work with you to meet tight clinical trial deadlines.
Language Scientific, Inc.® is a privately held corporation headquartered in Needham, Massachusetts.
Language Scientific, 100 Crescent Rd Needham, MA 02494
+1 617-621-0940
info@languagescientific.com
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