Quality is a part of everything we do.
Biora Therapeutics is ISO 13485 certified, demonstrating our commitment to compliance with the most rigorous global quality standards and our ability to meet exacting regulatory requirements. We are proud of the robust systems our team has built to ensure stringent control over development and manufacturing processes.
ISO 13485 is an internationally recognized quality standard for quality management systems, created by the International Organization for Standardization to ensure the safety and effectiveness of medical devices. It builds on the ISO 9001 standard with additional regulatory requirements specific to medical devices. In 2024, the FDA harmonized U.S. requirements with global standards through the adoption of ISO 13485 standards for medical devices.
