Quality System Overview

RayBiotech is committed to providing the highest quality products and services to its customers and maintains medical device certification to ISO 13485 requirements as a part of these efforts. This applies to our production facility and testing services facility and adds to our compliance of GLP/GMP 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 Inc is committed to meeting customer requirements. RayBiotech Inc works to achieve this by:

  1. Implementing and maintaining a formal Quality Management System QMS.
  2. Designing and developing processes, products, and services related to RayBiotech’s mission statement.
  3. Critical management and administrative support services to the products and services of RayBiotech.
  4. Continually improving and strengthening product and service quality by regular review of processes and products.
  5. Ensuring Senior management engages in the implementation of the QMS site-wide and that all products and processes meet regulatory and quality requirements

Manufacturing of Kits

All Raybiotech products are manufactured with high levels of production process control and rigorous quality control inspection processes to ensure each 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 new 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 the expectations of our customer to provide accurate reproducible results using samples you provide.


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.