ISO Certifications

EirMed is committed to providing a high standard of workmanship and quality in both our products and our processes. This is accomplished through:

  • FDA registered facilities
  • cGMP/QSR compliant
  • ISO 13485 & ISO 9001 certified facilities
  • ISO Class 7 cleanroom environments
  • ISO Class 8 cleanroom environments


ISO 9001

ISO 9001 specifies requirements for a quality management system for an organization