Normative base EN ISO 13485:2016 Medical devices – Quality Management System Reg. no. 45484 Validity 01.03.2022 – 28.02.2025 Issue 01.03.2022 Swiss Made Swiss Association for Quality and Management Systems (SQS) Bernstrasse 103, 3052 Zollikofen, Switzerland sqs.ch F.

Page 1 / 1 has been assessed and certified as meeting the requirements of ISO 14001:2015 For the following activities The Design and Manufacturing of Plastic Color Concentrated, Plastic Additive Concentrated and Pigment Powder for Thermoplastic & Rubber Industries. Certified since 06 September 2008 Jonathan Hall Global Head - Certification Services Authorised by SGS United Kingdom Ltd Rossmore Business Park, Ellesmere Port, Cheshire, CH65 3EN, UK t +44 (0)151 350-6666 - www.sgs.com https://www.sgs.com/en/terms-and-conditions/

For the plastics used in these medical applications, this can mean compliance with the relevant chapters of the International Organization for Standardization (ISO), the United States Pharmacopeia Class VI (USP VI) the European Pharmacopeia (EP 3.1), and the International Conference on Harmonization (ICH Q3D) standards and guidelines. All four sites are ISO 13485 certified and use a harmonized raw material range as the base for globally available Mevopur standard portfolios and for custom formulations. The raw materials are pre-tested to the relevant chapters of ISO 10991, USP 661, USP Class VI, EP 3.1 and to the ICH Q3D guidelines to help manufacturers increase the certainty of regulatory compliance for their devices and packaging.

For the plastics used in these medical applications, this can mean compliance with the relevant chapters of the International Organization for Standardization (ISO), the United States Pharmacopeia Class VI (USP VI) the European Pharmacopeia (EP 3.1), and the International Conference on Harmonization (ICH Q3D) standards and guidelines. All four sites are ISO 13485 certified and use a harmonized raw material range as the base for globally available Mevopur standard portfolios and for custom formulations. The raw materials are pre-tested to the relevant chapters of ISO 10991, USP 661, USP Class VI, EP 3.1 and to the ICH Q3D guidelines to help manufacturers increase the certainty of regulatory compliance for their devices and packaging.

For the plastics used in these medical applications, this can mean compliance with the relevant chapters of the International Organization for Standardization (ISO), the United States Pharmacopeia Class VI (USP VI) the European Pharmacopeia (EP 3.1), and the International Conference on Harmonization (ICH Q3D) standards and guidelines. All four sites are ISO 13485 certified and use a harmonized raw material range as the base for globally available Mevopur standard portfolios and for custom formulations. The raw materials are pre-tested to the relevant chapters of ISO 10991, USP 661, USP Class VI, EP 3.1 and to the ICH Q3D guidelines to help manufacturers increase the certainty of regulatory compliance for their devices and packaging.

For the plastics used in these medical applications, this can mean compliance with the relevant chapters of the International Organization for Standardization (ISO), the United States Pharmacopeia Class VI (USP VI) the European Pharmacopeia (EP 3.1), and the International Conference on Harmonization (ICH Q3D) standards and guidelines. All four sites are ISO 13485 certified and use a harmonized raw material range as the base for globally available Mevopur standard portfolios and for custom formulations. The raw materials are pre-tested to the relevant chapters of ISO 10991, USP 661, USP Class VI, EP 3.1 and to the ICH Q3D guidelines to help manufacturers increase the certainty of regulatory compliance for their devices and packaging.

For the plastics used in these medical applications, this can mean compliance with the relevant chapters of the International Organization for Standardization (ISO), the United States Pharmacopeia Class VI (USP VI) the European Pharmacopeia (EP 3.1), and the International Conference on Harmonization (ICH Q3D) standards and guidelines. All four sites are ISO 13485 certified and use a harmonized raw material range as the base for globally available Mevopur standard portfolios and for custom formulations. The raw materials are pre-tested to the relevant chapters of ISO 10991, USP 661, USP Class VI, EP 3.1 and to the ICH Q3D guidelines to help manufacturers increase the certainty of regulatory compliance for their devices and packaging.

For the plastics used in these medical applications, this can mean compliance with the relevant chapters of the International Organization for Standardization (ISO), the United States Pharmacopeia Class VI (USP VI) the European Pharmacopeia (EP 3.1), and the International Conference on Harmonization (ICH Q3D) standards and guidelines. All four sites are ISO 13485 certified and use a harmonized raw material range as the base for globally available Mevopur standard portfolios and for custom formulations. The raw materials are pre-tested to the relevant chapters of ISO 10991, USP 661, USP Class VI, EP 3.1 and to the ICH Q3D guidelines to help manufacturers increase the certainty of regulatory compliance for their devices and packaging.

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).

PolyOne Specialty Coatings and Inks Kennesaw, GA Plant Achieves ISO 9001-2008 Certification CLEVELAND – PolyOne today announced that its Specialty Coating and Inks plant in Kennesaw, GA recently achieved ISO 9001-2008 certification.