Navigating MDR & IVDR Compliance: Streamlining Localization with TrueLanguage
For medical device manufacturers, it is crucial to understand and comply with the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation IVDR for your products. These regulations have introduced significant changes and new requirements that affect various aspects of your product’s lifecycle, such as labeling, technical documentation, and clinical evidence. To assist you in successfully navigating these regulations, TrueLanguage offers comprehensive localization services with a team of regulatory experts, medical writers, and linguists who possess in-depth knowledge of the requirements and challenges.
Technical Translation and Localization Automation
We provide technical translation and localization automation services for various platforms, including websites, apps, software, e-learning modules, and in vitro diagnostic (IVD) devices. Our team is experienced in translating and adapting technical documentation, such as instructions for use (IFUs), labeling, and marketing materials. By accurately translating and localizing these materials, you can rest assured that your products are accessible to a global audience while complying with the language requirements of a wide range of markets.
Regulatory Assessment
To ensure compliance with MDR and IVDR, we thoroughly assess the regulatory status of each of your products. Our experts identify gaps in compliance and provide actionable recommendations to address these gaps. This assessment helps you understand the specific requirements applicable to your products and enables you to take the necessary steps to meet regulatory standards. By partnering with us, you can proactively address compliance issues and mitigate potential risks associated with non-compliance.
XML Content Management
We offer XML content management services, particularly for software content management systems (CMS) and product management systems (PMS). With our expertise in XML, these services assist in integrating your software systems seamlessly. This integration facilitates the efficient management and localization of your content, streamlining the localization process and reducing the potential for errors. By leveraging our XML content management capabilities, you can enhance the effectiveness and accuracy of your localization efforts.
Quality Assurance
Quality assurance is a crucial aspect of the localization process. We employ a rigorous quality assurance process to verify the accuracy and consistency of the translated content and check its compliance with applicable regulations. By adhering to TrueLanguage’s ISO certification requirements, we maintain stringent quality standards throughout the localization process. Our quality assurance measures guarantee that your localized materials are of the highest linguistic quality and satisfy all applicable regulations. This attention to detail helps you maintain product integrity and promote customer satisfaction.
Compliance with MDR and IVDR is essential for medical device manufacturers, and localization plays a vital role in meeting these requirements. TrueLanguage and our parent company Powerling offer comprehensive localization services tailored to the medical device industry, with a focus on technical translation, regulatory assessment, XML content management, and quality assurance. By partnering with our team of experts, you can lock in compliance, reduce the time and costs associated with localization, and improve overall efficiency. Outsourcing your localization process allows you to focus on core competencies, accelerate time-to-market, and confidently expand into global markets.
