Mevopur™ Colors and Functional Additives for In Vitro Diagnostic Devices - Application Bulletin Benefits of using Mevopur™ Colors and Functional Additives for in vitro diagnostic devices Medical Device Housing

Sealing in Medical Device Savings Medical Device Trays and Kits Medical Devices & Equipment

What are medical grade TPEs? Not surprisingly, the healthcare market has additional regulatory requirements for those creating medical products and devices. Additionally, automotive parts and devices made from TPE make vehicles lighter and more fuel efficient.

To help customers manage their risk potential, dedicated facilities and systems govern the production of our medical colorants and performance masterbatches. Declarations based on pre-testing of the ingredients we use to standards typically required for medical and diagnostic devices (biological evaluations ISO10993, USP , for class VI devices); and for pharmaceutical packaging and drug-contacting materials (biological evaluation USP, EP chapter and requirements USP and ICHQ3D extractable metals). Letter of Authority (LoA) for our Drug Master File (DMF) and Device Master File (MAF).

To help customers manage their risk potential, dedicated facilities and systems govern the production of our medical colorants and performance masterbatches. Declarations based on pre-testing of the ingredients we use to standards typically required for medical and diagnostic devices (biological evaluations ISO10993, USP , for class VI devices); and for pharmaceutical packaging and drug-contacting materials (biological evaluation USP, EP chapter and requirements USP and ICHQ3D extractable metals). Letter of Authority (LoA) for our Drug Master File (DMF) and Device Master File (MAF).

To help customers manage their risk potential, dedicated facilities and systems govern the production of our medical colorants and performance masterbatches. Declarations based on pre-testing of the ingredients we use to standards typically required for medical and diagnostic devices (biological evaluations ISO10993, USP , for class VI devices); and for pharmaceutical packaging and drug-contacting materials (biological evaluation USP, EP chapter and requirements USP and ICHQ3D extractable metals). Letter of Authority (LoA) for our Drug Master File (DMF) and Device Master File (MAF).

Food, Drug, Medical Avient currently has twenty-three facilities globally certified to the Corporation’s GMP program and two facilities certified to "ISO 13485, Medical Device - Quality Management Systems - Requirements for Regulatory Purposes." FDA Drug Master Files and Medical Application Files. 

Mevopur™ Healthcare Colorants and Formulations and Mevopur™ Healthcare Functional Additives for In Vitro Diagnostic Devices Diagnostic devices and consumables, now more than ever, play a vital role in delivery of safe treatements. Fast, accurate and reliable results aid medical professionals to understand the illness and develop the strategy for an effective treatment. 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 with all applicable laws and regulations, including the suitability of all raw materials and components used for its manufacture.

We collaborate with engineers, project managers and designers to assist you in achieving comprehensive device performance.  Explore polymer, colorant and additive solutions for catheters & medical tubing Antimicrobial corrosion and chemical resistant formulations to solve your medical application challenges

Disinfectant Resistance for Medical Device Housings - Case Study Manufacturer boosts disinfectant resistance for medical device housings using Trilliant HC High Performance Formulations