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Home News Good news: Far East Excellence Technology successfully passed ISO13485:2016 medical device quality management system certification

Good news: Far East Excellence Technology successfully passed ISO13485:2016 medical device quality management system certification

  • June 30, 2022

The ISO13485 standard is a quality management system standard applicable to medical device regulations. Its full name is "Medical Device Quality Management System Requirements for Regulations". It adopts the related concepts based on PDCA in the ISO9001 standard. Compared with the ISO9001 standard, which is applicable to all types of organizations, ISO13485 is more professional and focuses on the design and development, production, storage and circulation, installation, service and final deactivation of medical devices. and disposal and other related industry organizations. At present, organizations can establish systems or seek certification according to the ISO13485:2016 version of the standard. The types of organizations mainly involved in ISO13485 certification include: medical device designers and manufacturers, medical device operators, medical device service providers, medical device software and hardware developers, and medical device components/materials suppliers. The medical device industry has always used the ISO13485 standard as the basis for quality management assurance.


Far East Excellence successfully passed the ISO13485 certification to improve and improve the management level of the enterprise, avoid legal risks, and increase the visibility of the enterprise. Improve and ensure the quality of products, so that enterprises can obtain greater economic benefits and help eliminate trade barriers and obtain a passport to enter the international market. It is beneficial to enhance the competitiveness of products and increase the market share of products. Through effective risk management, effectively reducing the risk of product quality accidents or adverse events also improves employees' sense of responsibility, motivation and dedication.


ISO13485 certificate


Far East Excellence Technology has more than 15 years of experience in precision machining, and always adheres to the quality policy of "accurately grasping customer quality requirements, providing customers with high-quality products, continuous improvement and common development", and is strict and demanding on quality. The quality management team continuously optimizes the quality strategic goals, conducts comprehensive control from the production process to each link, and always strictly implements the process control and risk control required by the quality system documents, ensures the safety and accuracy of products, and continuously realizes quality and technology innovation. . For more information, please contact us.

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