https://www.avient.com/idea/changing-regulations-ivdr
Dedicated global technical centers and ISO 13485 certified manufacturing sites round out the service offer and provide consistent support for diagnostic devices.
https://www.avient.com/resource-center?document_type=59&page=0
NEU™ Custom Capabilities and NEUSoft™ Thermoplastic Polyurethanes are developed for short-term in-vivo applications that offer good elasticity, radiopacity, excellent UV stability and protection against moisture and oxygen while meeting ISO 10993 & USP Class VI standards. Edgetek™ Engineered Polymer Formulations achieved a UL 94 V-0 flammability rating certification for server cabinets Mevopur™ formulations for PCR well plates prevent 'cross-talk' and minimize phosphorescence with optimally dispersed TiO2, while balancing melt flow and physical properties, and ensuring quality through ISO 13485:2016 certification.
https://www.avient.com/resource-center?document_type=59&document_subtype=0&industry=0&product_family=0&product_name=0&op=FILTER RESULTS&form_id=resource_filter_form
NEU™ Custom Capabilities and NEUSoft™ Thermoplastic Polyurethanes are developed for short-term in-vivo applications that offer good elasticity, radiopacity, excellent UV stability and protection against moisture and oxygen while meeting ISO 10993 & USP Class VI standards. Edgetek™ Engineered Polymer Formulations achieved a UL 94 V-0 flammability rating certification for server cabinets Mevopur™ formulations for PCR well plates prevent 'cross-talk' and minimize phosphorescence with optimally dispersed TiO2, while balancing melt flow and physical properties, and ensuring quality through ISO 13485:2016 certification.
https://www.avient.com/news/avient-announces-expansion-neusoft-tpu-manufacturing-china-medtec-china-2024-enhancing-service-apac-customers
They are also certified to meet biocompatibility requirements for ISO 10993 and USP Class VI standards. Avient's Suzhou facility operates under ISO 13485 quality management system certification, complying with the leading standards in medical device manufacturing.
https://www.avient.com/news/avient-launches-two-new-sustainable-polymer-solutions-medical-and-pharmaceutical-applications-during-pharmapack-europe-2021
MEVOPUR medical-grade materials are produced according to ISO13485-2016 protocols and supported by testing to ISO 10993-1, USP, European Pharmacopeia and ICH Q3D guidelines.
https://www.avient.com/resource-center?document_type=0&industry=0&product_family=84&product_subfamily=0&product_name=0&op=FILTER RESULTS&form_build_id=form-fNS88LG3BRw1MCsEhxqrGzoCcCISeOxlsDfIOUV4Mx0&form_id=resource_filter_form&page=0
Mevopur™ formulations for PCR well plates prevent 'cross-talk' and minimize phosphorescence with optimally dispersed TiO2, while balancing melt flow and physical properties, and ensuring quality through ISO 13485:2016 certification.
https://www.avient.com/industries/healthcare/medical-devices-equipment/respiratory-care-anesthesiology
Polymer technologies manufactured under controlled conditions and ISO 13485-certified sites to meet strict regulatory requirements
https://www.avient.com/news/specialty-polymer-solutions-avient-improved-durability-and-sustainability-healthcare-products-pharmapack-2023
All materials in this range are formulated to comply with ISO 10993-4 and -5, REACH SVHC, and RoHS. All the materials are manufactured in ISO 13485-2016 certified sites and supported by testing to ISO 10993-1, USP, EP, and ICH Q3D protocols.
https://www.avient.com/resource-center?document_type=0&industry=0&product_family=84&product_subfamily=0&product_name=0&op=FILTER RESULTS&form_build_id=form-fNS88LG3BRw1MCsEhxqrGzoCcCISeOxlsDfIOUV4Mx0&form_id=resource_filter_form
Mevopur™ formulations for PCR well plates prevent 'cross-talk' and minimize phosphorescence with optimally dispersed TiO2, while balancing melt flow and physical properties, and ensuring quality through ISO 13485:2016 certification.
https://www.avient.com/resource-center?document_type=0&form_build_id=form-fNS88LG3BRw1MCsEhxqrGzoCcCISeOxlsDfIOUV4Mx0&form_id=resource_filter_form&industry=0&op=FILTER RESULTS&product_family=84&product_name=0&product_subfamily=0&page=0
Mevopur™ formulations for PCR well plates prevent 'cross-talk' and minimize phosphorescence with optimally dispersed TiO2, while balancing melt flow and physical properties, and ensuring quality through ISO 13485:2016 certification.