Assuring safety and quality
Asahi Kasei Medical acquired both ISO9001 certification and the CE Marking in 1994, becoming the first Japanese medical device manufacturer qualified under the European standard. The company has satisfied the Quality System Regulation (QSR) of the US Food and Drug Administration (FDA) and established a quality assurance system in compliance with ISO13485:2003, the internationally recognized standard for the manufacture and quality control of medical devices which satisfies regulations in different countries including the Japanese Quality Management System (QMS) ministerial ordinance.
As evidence of its sincere commitment to environmental preservation, its virus removal filters used in biotherapeutic production are also certified under the ISO14000 series. We are thus ready to provide advanced, high-quality products with assured safety to the global market.
Worldwide supply
Asahi Kasei Kuraray Medical and Asahi Kasei Medical operate plants in Oita and Nobeoka, Japan. The Oita plant specializes mainly in assembly of dialyzers, blood purification products, and leukoreduction filters and the Nobeoka plant mainly produces hollow-fiber membranes for dialyzers and industrial virus filters, both ranking among the largest in the global medical device industry.
Asahi Kasei Kuraray Medical also operates an overseas assembly plant for dialyzers in Hangzhou, China, to support worldwide distribution and to serve as a production base for the growing markets in the Far East, Southeast Asia, and Middle East. With its business development supported by outstanding R&D capability, we continue to strive for more efficient and stable production capacity as a world-class leading company for all its products including state-of-the-art polysulfone dialyzers.
