Specialty Polymers Regulatory Information
The product design and manufacturing operations for our engineering polymers are performed according to processes conforming to and registered under ISO 9001 / IATF 16949. This assures that the products you receive were designed and manufactured using an effective quality system.
Our US testing laboratories are accredited to ISO/IEC 17025 by the American Association for Laboratory Accreditation (A2LA). This assures the competence of our testing laboratories. Links to our certificates and scopes follow:
We are ISO 13485 registered for Solviva® Biomaterials offered for use in implantable medical devices: