Quality & Regulatory


Our products are manufactured by ISO 13485:2003 standards. We are registered with the FDA.

Our Quality Control Department ensures that we deliver consistent quality products to our customers. We pride ourselves for using a local USA based supply-base for all of our raw material and assembly needs.


We maintain a comprehensive Quality System that employs strategic tools to assist in risk management assessment activities such as,

  • Installation Qualification, ,Operation Qualification, and Process Qualification/Validation procedures
  • D/PFMEA – Design/Process Failure Modes Analysis.
  • SPC – Statistical Process Control.