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ISO13485 medical devices

Product introduction: ISO13485 is called 'medical device quality management system' in Chinese. Because medical devices are special products for saving lives and healing wounds, disease prevention and treatment, it is not enough to regulate them only according to the general requirements of ISO9000 standard. Therefore, ISO has issued iso13485:1996 standards (YY / T0287 and YY / t0288), which put forward special requirements for the quality management system of medical device manufacturers, and played a good role in promoting the safety and effectiveness of the quality of medical devices.ISO13485 is a quality management system for the medical device industry based on the ISO9001 process method, which is used to meet the requirements of laws and regulations. It includes special requirements for the manufacturing, installation, service and recall of medical devices, so as to:-Improve the quality management system-Risk management method is used to control the product realization process-Process validation-Meet the requirements of laws and regulations-Effectively control product risk and recall managementBenefits of ISO13485 certification-It helps to eliminate technical barriers in international trade and is a pass to enter the international market-Improve the management level of the organization-Improve business reputation-Improve the level of ensuring product quality-It is conducive to enhancing the competitiveness of enterprises-Improve the internal management of the organization
Project introduction: ISO13485 is a quality management system for medical device industry based on ISO9001 process method, which is used to meet the requirements of laws and regulations. It includes special requirements for the manufacturing, installation, service and recall of medical devices.
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ISO13485 medical devices
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  • Certification application

ISO13485 is called 'medical device quality management system' in Chinese. Because medical devices are special products for saving lives and healing wounds, disease prevention and treatment, it is not enough to regulate them only according to the general requirements of ISO9000 standard. Therefore, ISO has issued iso13485:1996 standards (YY / T0287 and YY / t0288), which put forward special requirements for the quality management system of medical device manufacturers, and played a good role in promoting the safety and effectiveness of the quality of medical devices.

ISO13485 is a quality management system for the medical device industry based on the ISO9001 process method, which is used to meet the requirements of laws and regulations. It includes special requirements for the manufacturing, installation, service and recall of medical devices, so as to:

-Improve the quality management system
-Risk management method is used to control the product realization process
-Process validation
-Meet the requirements of laws and regulations
-Effectively control product risk and recall management


Benefits of ISO13485 certification
-It helps to eliminate technical barriers in international trade and is a pass to enter the international market
-Improve the management level of the organization
-Improve business reputation
-Improve the level of ensuring product quality
-It is conducive to enhancing the competitiveness of enterprises
-Improve the internal management of the organization

ISO13485 is called 'medical device quality management system' in Chinese. Because medical devices are special products for saving lives and healing wounds, disease prevention and treatment, it is not enough to regulate them only according to the general requirements of ISO9000 standard. Therefore, ISO has issued iso13485:1996 standards (YY / T0287 and YY / t0288), which put forward special requirements for the quality management system of medical device manufacturers, and played a good role in promoting the safety and effectiveness of the quality of medical devices.

ISO13485 is a quality management system for the medical device industry based on the ISO9001 process method, which is used to meet the requirements of laws and regulations. It includes special requirements for the manufacturing, installation, service and recall of medical devices, so as to:

-Improve the quality management system
-Risk management method is used to control the product realization process
-Process validation
-Meet the requirements of laws and regulations
-Effectively control product risk and recall management


Benefits of ISO13485 certification
-It helps to eliminate technical barriers in international trade and is a pass to enter the international market
-Improve the management level of the organization
-Improve business reputation
-Improve the level of ensuring product quality
-It is conducive to enhancing the competitiveness of enterprises
-Improve the internal management of the organization

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