ISO 13485, as an international standard for quality management systems in the medical device industry, focuses on ensuring that manufacturers and service providers of medical devices adhere to a set of scientific and rigorous quality management processes to ensure the safety, efficacy, and compliance of products. With this certification, Xinyu Wisdom has demonstrated its ability to deeply understand and meet the unique regulatory, standard, and customer requirements of the medical device industry, providing solid language support for the internationalization of the global medical device market.
Xinyu Wisdom is deeply involved in five major fields: ICT, life sciences, gaming, financial services, and patents. With a continuous pursuit of quality and a spirit of excellence, the company has established an outstanding reputation in each field. Especially in the field of life sciences, the company emphasizes the professionalism and compliance of medical device translation, ensuring the accuracy of translation content, understanding the regulatory requirements of various countries and regions, and helping customers' products enter the international market without barriers.
To successfully pass the ISO 13485 certification, Xinyu Wisdom not only organized translators to delve into the study of medical device-related standards and regulations but also continuously optimized internal processes and resource management, establishing a comprehensive quality management system. This system has not only improved the efficiency and accuracy of translation services but also further consolidated the company's leading position in the industry.
It is worth mentioning that Xinyu Wisdom also holds a series of international quality management system certifications, including ISO 9001 (Quality Management), ISO 17100 (Translation Services), ISO 27001 (Information Security), ISO 14001 (Environmental Management), and ISO 45001 (Occupational Health and Safety), fully demonstrating the company's outstanding performance in various aspects such as quality management, information security, environmental protection, and employee health and safety.
Looking forward, Xinyu Wisdom will continue to adhere to the "accurate, reliable, and efficient" service philosophy, relying on its strong translation team and advanced quality management system, to provide more professional and high-quality multilingual translation services for the global medical device industry, helping customers' products to be successfully promoted and applied in the worldwide market.
