Major industrial rubber manufacturer Fujikura Rubber Ltd. (TYO:5121) recently obtained ISO 13485:2016 certification, the international standard for quality management systems of medical devices. In contrast to the ISO 9001:2015 standard, ISO 13485:2016 comes chiefly aimed at medical device manufacturers. It seeks conformity with regulatory requirements these devices, adding in risk management, cleanliness, pollution control and other such requirements specific to...
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