Quality Systems

RayBiotech is committed to providing the highest quality products and services to our customers, and we maintain certification to ISO 13485:2016, cGMP, and ISO 17025:2017 as a part of these efforts. This certification applies to our production facility and testing services facility and adds to our compliance with GLP FDA regulations.

As we look to the future, RayBiotech will continue to ensure that our products and testing services maintain and exceed this high standard of quality through our continuous improvement program.

Quality Policy

RayBiotech is committed to meeting and exceeding customer expectations for quality, performance, and regulatory compliance. We achieve this through the following:

  • Implementing and maintaining a formal Quality Management System (QMS).
  • Designing and developing processes, products, and services related to RayBiotech’s mission statement.
  • Delivering critical management and administrative support services to the products and services of RayBiotech.
  • Continually improving and strengthening product and service quality by regular review of processes and products.
  • Ensuring senior management engages in the implementation of the QMS site-wide and that all products and processes meet regulatory and quality requirements.

Kit Manufacturing

All Raybiotech products are manufactured with high levels of production process control and rigorous quality control inspection processes to ensure that product meets specified requirements and customer expectations. Inherent with this are validated design and production process specifications, ensuring consistent product quality and reliability.

GLP Testing Services Facility

Raybiotech prides itself in providing testing services in its state-of-the-art GLP facility that complies with FDA regulations 21CFR58. Our commitment to quality ensures a complete testing and reporting system that is validated and designed to meet your expectations around receiving accurate and reproducible results using samples you provide. A subset of pre-established assays are also available under a GCLP testing service scope and the ability to customize and expand these GLP/GCLP/GMP needs is available.


Our Research Use Only products are in compliance with FDA regulations; they are freely marketed in the U.S.; and are in compliance with all U.S. laws and regulations.