© Prestige Ameritech  |  All products made in the USA  |  ISO 13485:2016 Certified, FDA Registered Facility

HUB Certified Small Business  |  TERO Certified Native American Owned Business

 

When you do business with Prestige Ameritech, you can rest assured that we are compliant to all quality and safety requirements of a medical device manufacturer.

 

ISO 13485:2016 Certified

ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services.

 

FDA Registered Facility

FDA's Center for Devices and Radiological Health (CDRH) is responsible for regulating firms who manufacture, repackage, relabel, and/or import medical devices sold in the United States. Our facility underwent FDA inspections to assure compliance with the FDA requirements before it was listed as a registered facility.

 

HUBZone Certified Small Business

The Historically Underutilized Business Zones (HUBZone) program was enacted into law as part of the Small Business Reauthorization Act of 1997.

The program encourages economic development in historically underutilized business zones - "HUBZones" - through the establishment of preferences.

Small Business Administration's HUBZone program is in line with the efforts of both the Administration and Congress to promote economic development and employment growth in distressed areas by providing access to more federal contracting opportunities.

 

TERO Certified Native American Owned Business

Prestige Ameritech is certified as a Native American Owned Business by the Cherokee Nation Tribal Employment Rights Office (TERO).