Asahi Rubber’s Shirakawa No. 2 Plant in Shirakawa City, Fukushima Prefecture, has acquired ISO 13485 certification, an international quality management system standard for medical devices. The company is developing its medical and life science business alongside its optical, functional, and telecommunications businesses, and is currently manufacturing rubber stoppers for intravenous infusion bags as well as mixing medications, and the AR...
iso certification
Fujikura Rubber Acquires ISO Certification for Medical Device Quality Management Systems
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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