Certifications

We are committed to compliance. Biomerics is registered with the FDA and maintains ISO 13485 certifications and foreign manufacturer registrations.

These credentials allow us to manufacture medical devices and components in compliance with FDA requirements, CE Mark requirements, and other medical device governing body requirements throughout the world.

ISO 13485 certificates

• Salt Lake City, Utah

• Brooklyn Park, Minnesota

• Athens, Texas

• Monroe, Connecticut

• Cartago, Costa Rica

• Santa Clara, California

• Galway, Ireland

• Alajuela, Costa Rica

• Winston-Salem, North Carolina

ISO 9001 certificate

• Fairfield, California

• Alajuela, Costa Rica

• Haina, Dominican Republic

• Harrisonburg, Virginia

• Mebane, North Carolina

• Winston-Salem, North Carolina

Foreign manufacturer registration

• Japan

• Brazil

FDA Registrations

• Winston-Salem, North Carolina

National Veteran Business Development Council (NVBDC)

• Winston-Salem, North Carolina