https://www.avient.com/resource-center/knowledge-base/article/regulatory-issues-0?ind%5B0%5D=6598
Manufacturing medical devices?
FDA Drug Master Files and Medical Application Files.
Article Medical Hose Manufacturer Boosts Productivity With Specialized Material
Medical hose manufacturer boosts productivity With specialized material.
https://www.avient.com/resource-center/knowledge-base/article/regulatory-issues-0?ind%5B0%5D=21508
Manufacturing medical devices?
FDA Drug Master Files and Medical Application Files.
Article Medical Hose Manufacturer Boosts Productivity With Specialized Material
Medical hose manufacturer boosts productivity With specialized material.
https://www.avient.com/resource-center/knowledge-base/article/regulatory-issues-0
Manufacturing medical devices?
FDA Drug Master Files and Medical Application Files.
Article Medical Hose Manufacturer Boosts Productivity With Specialized Material
Medical hose manufacturer boosts productivity With specialized material.
https://www.avient.com/news/avient-site-taiwan-earns-iso-13485-accreditation-fourth-source-mevopur-medical-grade-materials
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Avient Site in Taiwan Earns ISO 13485 Accreditation; Fourth Source for MEVOPUR™ ‘Medical-Grade’ Materials
Say-Eng Lee, vice president and general manager, Color & Additives Asia says, “China and other Asian countries not only have a rapidly growing domestic healthcare market, but they are also actively supporting Western countries for medical product manufacturing, where they need to meet strict medical- and pharma-related standards for testing, traceability, and change control of the materials used in their products.
We aim to limit non-compliance risk and support safety in use by using only raw materials that have been specially tested in accordance with medical standards.
https://www.avient.com/news/polyone-expands-pre-certified-biocompatible-healthcare-portfolio
All OnColor™ HC Plus colorants include formulation lock-down provisions, and are suitable for specialized pharmaceutical goods and medical devices.
CAPTION: PolyOne has developed five new medical-grade polymer carriers within itsOnColor™ HC Plus portfolio.
All thirteen medical-grade carrier materials in the portfolio are pre-certified to meet or exceed ISO 10993 and/or USP Class VI requirements for applications ranging from medical packaging to device housings.
https://www.avient.com/products/polymer-colorants/high-temperature-color-concentrates/colorant-chromatics-transcend-biocompatible-peek-pre-colored-compounds
Passed ISO 10993 biocompatibility testing, suitable for medical use
Excellent for dental scalers, surgical robots, medical stock & shapes, and portable cardiac monitoring devices
Complies with medical regulations and manufactured under Avient's Good Manufacturing Practice (GMP) standards
https://www.avient.com/news/avient-shares-customer-success-healthcare-high-temperature-pre-colored-solutions-k-2022
However, medical devices and instruments are frequently exposed to harsh temperatures and chemicals for cleaning and disinfecting, which can diminish safety and color.
By color-coding its orthopedic devices, the customer was able to help medical professionals more easily determine which size of prosthesis would fit best for a patient.
When this medical device manufacturer first came to us for help distinguishing its medical instruments, we knew our Colorant Chromatics Transcend pre-colored solutions could help address its needs,” said Anne Hippert, general manager, Colorant Chromatics at Avient.
https://www.avient.com/products/engineered-polymer-formulations/chemical-corrosion-resistant-formulations/trilliant-hc-healthcare-thermoplastics
Medical Device Housings
Auto-Injector Housing - Medical Delivery Device
Medical Device Housing
https://www.avient.com/products/polymer-colorants/healthcare-colorants/mevopur-healthcare-colorants-and-formulations
Medical devices, pharmaceutical packaging
Medical Grade Colorants and Additives for Wearable Medical Devices
Discover more about Avient medical grade colorant and additives for wearable medical devices.
https://www.avient.com/news/polyone-features-total-portfolio-healthcare-polymers-and-colorants-mdm-west-2017
– At Medical Design and Manufacturing (MD&M) West 2017 this week, PolyOne is demonstrating commercial medical products designed and built from its comprehensive portfolio of technologies for the healthcare industry.
With one of the widest and deepest collections of regulatory-compliant medical polymers and colorants available, we’re able to collaborate with manufacturers to help them successfully develop next-generation products,” said Cathy Dodd, vice president, marketing, PolyOne.
PolyOne Distribution:
• Expert team works with medical device customers to provide a combination of resources, technical understanding and material solutions to help discover the polymer formulations that are ideal for specific applications