ARKRAY is committed to producing safe, reliable, and effective products and services that meet or exceed customer requirements. To achieve this, the ARKRAY family of products is manufactured in compliance with strict industry standards including the U.S. FDA Quality System Regulation and ISO 13485.

Establishment Registration and Device Listing [PDF]
ISO 13485 Certification - ARKRAY USA [PDF]
ISO 13485 Certification - ARKRAY Japan [PDF]