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

Certification

ISO 9001

ISO 9001 specifies requirements for a quality management system for an organization’s ability to provide products and services that meet regulatory requirements.

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Certification

ISO 13485

ISO 13485 specifies requirements for a quality management system for an organization’s ability to provide medical devices and related services.

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