About ARKRAY USA

Corporate Overview

For more than 60 years, ARKRAY has developed innovative diagnostic and monitoring products including automated systems for urinalysis, A1C, clinical chemistry instruments, reagents and consumables. In addition, ARKRAY is a leader in the blood glucose monitoring market with a dominant market share in long term care. ARKRAY continues to evolve and innovate its product lines and programs to meet the changing needs of the industry including oral wellness innovations that benefit patients and provide health care professionals with new tools to care for them. For healthcare providers, this means access to cutting edge and reliable products combined with superior customer support. With products and programs that reach throughout the industry, ARKRAY has become the trusted source across the healthcare continuum.

Quality Management System

ARKRAY USA implements a Quality Management System and Quality Policy that aligns with the purpose of our global organization as communicated through ARKRAY's Group Mission and Vision statements.

ARKRAY Group Mission

ARKRAY's mission is to contribute to the health and well-being of people all over the world through the advancement of science and discovery of new technologies

ARKRAY Group Vision

ARKRAY's vision is to positively influence society through sound, legitimate business practices

We are committed to understanding US customer and regulatory requirements and providing products, services and expertise to meet those requirements. We accomplish this by:

  • Developing strong relationships with our suppliers, distributors and customers, and
  • Establishing a quality system compliant with ISO 13485:2016 and 21 CFR Part 820 that includes processes, procedures, operations and resources needed to support the business.

Our Quality Policy reflects our commitment to quality and ARKRAY's Group Mission and Vision statements.

ARKRAY Quality Policy

ARKRAY is committed to providing quality products and services that meet customer and regulatory requirements. We establish quality objectives throughout the organization to ensure continued suitability, adequacy and effectiveness of the Quality Management System.

A copy of our ISO 13485:2016 can be found here.

Code of Conduct

ARKRAY is committed to meeting ethical standards and complying with all applicable local, national and international laws wherever we do business. Ethical behavior in business is essential to creating and maintaining a fair environment for all. For that reason, we maintain internal processes and procedures to ensure that our employees adhere to the laws, regulations and industry codes of conduct that support good business practices.

Click here to view ARKRAY's code of conduct manual.

Click here to view California declaration of compliance - 2022