Quality Standards

Trinity Biotech is committed to providing quality products for the diagnostics market. Our US and Irish facilities are each FDA and ISO registered facilities.

Trinity Biotech manufacturing sites are accredited with the following ISO standards:

  • ISO 9001
  • ISO 13485
  • CAN/CSA ISO 13485.03

Each manufacturing site is certified by an internationally recognised notified body. This serves as external verification that Trinity Biotech has an established and effective quality system in accordance with an internationally recognised standard.

Please contact Trinity Biotech for further information.