https://www.avient.com/news/archives?page=34
Avient To Add Further Capacity For Medical-Grade Mevopur™ Materials in Asia Pacific
https://www.avient.com/news/archives?page=43
– February 4, 2019 – At Medical Design and Manufacturing (MD&M) West this week, PolyOne is highlighting its extensive portfoli
https://www.avient.com/news/archives?page=28
Avient Site in Taiwan Earns ISO 13485 Accreditation; Fourth Source for MEVOPUR™ ‘Medical-Grade’ Materials
https://www.avient.com/news/archives?page=82
PolyOne Geon™ HC Solutions Stand Up to Medical Disinfectants
https://www.avient.com/resource-center/knowledge-base/case-study/new-approach-restores-efficiency-pulmonary-device-manufacturing?rtype%5B0%5D=1124
A leading medical contract manufacturer faced an unacceptably high number of rejected parts for a pulmonary device housing.
https://www.avient.com/resource-center/knowledge-base/case-study/new-approach-restores-efficiency-pulmonary-device-manufacturing?ind%5B0%5D=6598
A leading medical contract manufacturer faced an unacceptably high number of rejected parts for a pulmonary device housing.
https://www.avient.com/news/archives?page=77
PolyOne Expands Healthcare Portfolio with Biomerics’ Specialty Medical Solutions
https://www.avient.com/news/archives?page=68
PolyOne Showcases New Solutions for Medical Training Models at MD&M West 2014
https://www.avient.com/sites/default/files/2021-10/remafin-ep-white-masterbatches-for-pharma-application-bulletin_0.pdf
Avient products have not been designed for nor are they promoted or intended for use in: (a) medical devices categorized by either the United States Food and Drug Administration (FDA) or the International Standards Organization (ISO) as an “implant” device; or “Permanent” as defined under US Pharmacopoeia (USP) or ISO standards; or (b) active implantable medical devices as defined in EU Directive 90/385/EEC as amended; or (c) medical devices for “Long Term” use as defined in EU Directive 93/42/EEC as amended.
Without limiting the generality of this statement, Avient products shall not be used in any medical device application intended for: (1) exposure to human tissue or body fluids for 30 days or greater; (2) “plastic” (cosmetic or reconstructive) surgery use; (3) reproductive implants or any birth control device; or (4) any critical component in a permanently (greater than 30 days) implanted medical device that supports or sustains human life.
It is the responsibility of the medical device manufacturer and the person placing the medical device on the market to ensure compliance of the medical device, including the suitability of all raw materials and components used for its manufacture, and with all applicable laws and regulations. 1.844.4AVIENT www.avient.com
https://www.avient.com/sites/default/files/2020-07/case-study-one-pager-versalloy-infusion-adapter-port.pdf
MEDICAL EQUIPMENT MANUFACTURER C L O S E D S Y S T E M D R U G T R A N S F E R D E V I C E • A new material for a seal inside the next generation of closed system drug transfer device • Compliance with stringent regulatory standards: • Biocompatibility to ISO10993 • USP VI compliance • Provided regulatory support services and expertise throughout extensive medical approval process • Provided a custom formulation compliant with the highest healthcare regulatory standards • Enabled material to be manufactured and shipped globally Custom Versalloy™ HC 9220-90 Formulation KEY REQUIREMENTS WHY AVIENT?
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