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/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/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
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.
https://www.avient.com/news/specialty-and-sustainable-healthcare-material-solutions-avient-medtec-china-2023
Like other Mevopur formulations, they are manufactured in dedicated ISO 13485 facilities and supported by testing to ISO 10993-1, USP, European Pharmacopeia, and ICH Q3D guidelines.
They can be customized to meet specific regulatory demands such as USP Class VI, FDA CFR, and ISO 10993.
Versaflex™ HC 2110-57B TPEs comply with ISO 10993-4, ISO 10993-5, and USP Class VI and are suitable for Ethylene Oxide (EtO) sterilization without residue or allergens.
https://www.avient.com/news/avient-s-malm-sweden-site-earns-iscc-plus-certification-mevopur-healthcare-bio-based-polymer-solutions
Like other Mevopur products, the bio-based polymer solutions are formulated with raw materials pre-tested to ISO, USP, EP, and ICH Q3D protocols, supporting their compliance with safety and regulatory requirements for use in healthcare.
In Europe, Mevopur concentrates and ready-to-use formulations are manufactured in the ISO 13485-2016 certified site of Malmö, Sweden.
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/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/drug-delivery-systems/auto-injectors-and-drug-delivery-pens
ISO 13485 certified manufacturing sites
ISO 10993 and USP Class VI compliant solutions
