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