Homepage // News Center // Avient Site in Glendale, Arizona Earns ISO 13485 Certification The Avient facility in Glendale, AZ recently received ISO 13485 certification demonstrating the company’s commitment to providing healthcare solutions. The ISO 13485 certification signifies that these products are manufactured and delivered with the highest level of quality and compliance.  

Avient Site in Glendale, Arizona Earns ISO 13485 Certification The Avient facility in Glendale, AZ recently received ISO 13485 certification demonstrating the company’s commitment to providing healthcare solutio

标题：Avient Corporation today announced the ISO 13485:2016 certification of its production site in Taoyuan, Taiwan (near Taipei). TAOYUAN, Taiwan – 2022年1月19日 – Avient Corporation, a premier provider of specialized and sustainable material solutions and services, today announced the ISO 13485:2016 certification of its production site in Taoyuan, Taiwan (near Taipei).  ISO 13485 certification is the culmination of two years’ work to create a completely segregated, dedicated healthcare operation similar to other MEVOPUR plants.

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To support this, Avient’s medical-grade colorants and additives are manufactured at sites certified under GMP or ISO 13485-2016 standards. Mevopur™ Healthcare Colorants and Functional Additives: formulations pre-tested to support compliance with regulatory requirements, such as USP Class VI, ISO 10993, EP3.1, USP661.1, and ICH Q3D and manufactured across a global network of ISO 13485-certified facilities or under GMP certifications. They are manufactured at an ISO13485-2016-certified site and pre-tested to specific regulatory demands, including USP Class VI and ISO 10993.

Avient Site in Taiwan Earns ISO 13485 Accreditation; Fourth Source for MEVOPUR™ ‘Medical-Grade’ Materials Caption: Avient Corporation today announced the ISO 13485:2016 certification of its production site in Taoyuan, Taiwan (near Taipei).

MSC Certificate Place and date: For the issuing office: Høvik, 23 January 2025 DNV Product Assurance AS Veritasveien 1, 1363 Høvik, Norway Cecilie Gudesen Torp Management Representative Lack of fulfilment of conditions as set out in the Certification Agreement may render this Certificate invalid. ICP-4-5-i5-ISO13485-f1 rev2 ACCREDITED UNIT: DNV Product Assurance AS, Veritasveien 1, 1363 Høvik, Norway - TEL: +47 67 57 99 00. www.dnv.com MANAGEMENT SYSTEM CERTIFICATE Certificate no.: 240625-2017-AQ-RGC-NA-PS Initial certification date: 14 September 2017 Valid: 08 February 2025 – 07 February 2028 This is to certify that the management system of PolyOne-Shanghai, China 88 Guoshoujing Road, Z.J.Hi-Tech Park, Pudong Shanghai, China (Unicode: 91310000607342402D) has been found to conform to the Quality Management System standard: ISO 13485:2016 This certificate is valid for the following scope: Design, Manufacture, Sales and Distribution of Medical Colour and Additive Concentrates Used for the Plastic Parts of Medical Devices http://www.dnv.com

In addition, some specialized products are produced in internally-certified sites operating under the same ISO13485 Standard Operating Procedures (SOP).     Common global Quality Management System (QMS) with external ISO13485 GMP certification of the 3 dedicated production units, and conducting annual internal and external audits. Internal ISO13485 GMP is in operation at two additional specialist sites in Europe. •    Documented design review and consultation before we begin development.

Homepage // News Center // Avient’s Singapore Production Facility Receives ISCC PLUS Certification for Bio-Derived Materials The ISCC PLUS certification uses a mass balance chain-of-custody approach, which involves third-party accounting and tracking of the bio-sourced content in materials. This certification, in conjunction with the facility’s existing ISO 22000-certified Food Safety Management System and ISO 13485-certified Quality Management System for medical devices, also positions the Chin Bee site to meet stringent hygiene and regulatory requirements for products for mothers and children, food-contact packaging, and the medical and pharmaceutical industries.

The new line will be installed at the EN-ISO13485-2016 certified site, and complements similar capabilities in North America and Europe. As part of a global network of ISO13485 sites established starting in 2010, the Singapore facility also plays an important role in supporting product development globally.