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Avient: Fourth Source for Medical-Grade Materials in Taiwan accredited

Avient: Fourth Source for Medical-Grade Materials in Taiwan accredited

News 20.01.2022
PR Taiwan ISO News Detail
Avient Corporation announced the ISO certification of its production site in Taoyuan, Taiwan (near Taipei)

Avient Corporation  announced the ISO 13485:2016 certification of its production site in Taoyuan, Taiwan (near Taipei).

The plant, which is already fully operational, becomes the fourth global source for MEVOPUR™ polymer solutions, which are produced under carefully controlled conditions to support more reliable compliance with regulations governing medical devices and pharmaceutical packaging. Other sites are located in Lewiston, Maine (USA), Malmö, Sweden and Singapore.

The facility will allow Avient to better serve the booming healthcare market in China and the greater Asia-Pacific region. Say-Eng Lee, vice president and general manager, Color & Additives Asia says, “China and other Asian countries not only have a rapidly growing domestic healthcare market, but they are also actively supporting Western countries for medical product manufacturing, where they need to meet strict medical- and pharma-related standards for testing, traceability, and change control of the materials used in their products. This is where the MEVOPUR product line, and local availability from Taiwan, become extremely important.”

The Taoyuan site has extensive experience in providing customers with solutions that meet demanding requirements such as technical challenges, risk mitigation, and quality consistency. ISO 13485 certification is the culmination of two years’ work to create a completely segregated, dedicated healthcare operation similar to other MEVOPUR plants. The site features multiple full-scale extrusion lines capable of meeting a wide variety of customer needs. These are supported by laboratory facilities as well as technical and commercial teams that are thoroughly trained in risk assessment and change management, according to global MEVOPUR standards.

“The goal behind the MEVOPUR concept is to help customers navigate more easily through a changing regulatory landscape,” explains Volker Dickfeld, global marketing manager Healthcare. “We aim to limit non-compliance risk and support safety in use by using only raw materials that have been specially tested in accordance with medical standards.”

 

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