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.