Argen's Standards and Certifications

Argen operates under the auspices of the U.S. Food and Drug Administration and complies with their Good Manufacturing Practices. Argen's quality system is ISO 13485 certified. Tests are performed in accordance with ISO harmonized standards. Where applicable, individual alloys are further certified to meet NIOM, ADA or DIN standards.

What does all this mean to you? Third party certification of our Quality System via ISO 13485 means that our entire operation including research, purchasing raw materials, manufacturing, technical and customer services, has been independently audited to meet international standards. The CE mark further confirms that the materials have been determined to be safe and effective for their intended purpose.