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Time: 2017 - 06 - 09
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 r...
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