ISO 13485 certified manufacturing sites ISO 10993 and USP Class VI compliant solutions

Mevopur™ Healthcare Colorants, Functional Additives, and Bio-based Formulations: Manufactured across a global network of ISO 13485 facilities, this broad portfolio is pre-tested to United States Pharmacopeia (USP) Class VI, ISO 10993, USP 661, European Pharmacopeia 3.1, and International Conference on Harmonization (ICH) Q3D protocols.

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.

Global ISO Certificate Library

Global ISO Certificate Library

Global ISO Certificate Library

We have composite pellet manufacturing in North America and Europe guided by the ISO 9001:2015 certified quality system. 

These include ISO pre-certified colorants; FDA-compliant materials from engineering thermoplastics and elastomers to vinyl, styrenics and olefins; RoHS and REACH compliant materials; and much more.

All eight grades in the new series are also ISO 10993-4 and -5, REACH SVHC, and RoHS compliant.

They are available in certified USP Class VI and ISO 10993 compositions.