We maintain the following certificates as part of our quality system. Visit our certifications page to view or download a copy of each certificate.

  • FDA CDRH Registration: Contract Manufacturer, Contract Sterilizer
  • State of California: Device Manufacturing License
  • State of California: Drug Manufacturing License>
  • State of California: Drug Wholesaler License
  • International Standard I.S. EN ISO 13485
  • International Standard ISO 17665:2006 Moist Heat Sterilization
  • ISTA Certified Package Testing Laboratory
  • Japan Minister of Health: Medical Device Manufacturer, Sterile and Non Sterile Devices