Quality Certificates
Manufacturing Quality Certificates
BioFire Defense’s manufacturing processes adhere to stringent international quality management systems, ensuring the reliability and performance of every BioFire Defense product.
- ISO 9001 Certificate
- ISO 13485 Certificate
- MDSAP Certificate
- Certificate of CMMC Status of Final CMMC Level 2 (C3PAO)
- RE Nº 2.529-CBPF, Certificate of Good Manufacturing Practice of Health Products: Diagnostic products for in vitro use in Class III
- Japan Registration of in vitro diagnostic Manufacturer
Additional Resources
For further information regarding our quality assurance, product specifications, or regulatory compliance, please explore the resource center.