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What is ISO13485 certification 2022-03-24
The full name of the ISO13485:2003 standard is "Medical device-Quality management system-requirements for regulatory&quo...
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ISO13485-Medical Device Quality Management System Certification Consulting 2022-03-24
ISO13485:2003 has been officially promulgated, and this standard will cancel and replace ISO13485:1996 and ISO13488:1996 (equ...
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Medical Device Quality Management System 2022-03-24
Medical Device Quality Management System "Medical Device Quality Management System" is also called ISO13485Since me...
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What documents do companies need to prepare for ISO13485 certification? 2022-03-24
To apply for medical device quality certification, the following materials should be submitted to the certification body: Th...
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Enterprises apply for ISO3485 certification conditions 2022-03-24
Revision and adjustment of medical device quality certification registration conditions and application material requirements...
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The difference between ISO13485 and ISO9001 in the medical device industry 2022-03-24
The medical device industry has always used the ISO13485 standard (my country's equivalent standard number is YY/T 0287) ...
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Ten basic considerations for ISO13485:2009 2022-03-24
1) ISO13485:2003 is based on the process model of ISO9001:2000.2) ISO13485:2003 is established based on the model of quality ...
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Similarities and differences between ISO/DIS 13485 and ISO9001:2000 2022-03-24
ISO/DIS13485 is based on ISO9001:2000. It adopts the structure and main content of each chapter and article of ISO9001:2000. ...
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How ISO13485 Classifies Medical Devices 2022-03-24
The classification principles of ISO13485 medical devices are mainly based on their characteristics, such as non-invasive dev...
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New edition standard of IEC60601-1 (ISO13485) for medical equipment industry 2022-03-24
The third edition of IEC60601-1 ISO13485 will have a great impact on medical device manufacturers and certification organizat...