The Quality and Regulatory Affairs group ensures that our products are delivered with the highest level of quality possible. We take a holistic view of the products, verifying that all of the components of the products work together smoothly and seamlessly by designing comprehensive testing protocols. This group is also responsible for maintaining the company's quality system, ensuring that our products and company standards comply with rigorous federal regulations.

  • Extensive experience in validation and verification, we have obtained numerous U.S. Food and Drug Administration (FDA) 510(k) clearances for products we developed
  • Audited by numerous third parties, including customers and the U.S. FDA