Certifications Certifications You can rely on Darleys surgical for the top-quality surgical instruments.. We are committed to innovation, quality and legal standards. All of our manufacturing facilities are FDA cGMP, ISO (9001:2008, 13485:2003) and CE-Mark Certified Request to Download ISO-9001 Request to Download FDA Request to Download CE Request to Download GMP Request to Download SCCI Request to Download ISO-13485