quality_and_regulatoryAvalon is a contract manufacturer for many of the top medical device manufacturers in the global healthcare industry. We currently operate two FDA registered and ISO 13485 certified facilities (Rancho Dominguez, CA and Guaymas, Mexico). Dekra is Registrar for the ISO certification. Our Quality Management System is designed to ensure compliance with FDA Quality System Requirements (21 CFR 820) as well as requirements of ISO 13485 and associated standards.

Avalon has an experienced Regulatory Department that can assist with product approvals including FDA 510(k)’s and technical files for CE Marking.

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Avalon ISO 13485 Certificate