Quality certificates - Manufacturing

Please find below our Manufacturing Quality Certificates and click on the link to consult the document.

Australia	BTF - ISO GUIDE 34 ISO 17025 ISO 9001
Brazil	ANVISA ISO 9001 ISO 13485
China	ISO 9001 - INDUSTRY ISO 9001 - IVD ISO 13485
France	ISO 9001 - CLINICAL ISO 9001 - INDUSTRY and ENVIRONMENT ISO 13485 MDSAP
Italy	ISO 13485 ISO 9001 - CLINICAL ISO 9001 - INDUSTRY
Spain	ISO 9001 ISO 13485
USA	ISO 9001 ISO 13485 MDSAP
USA - Lombard	ISO 9001
USA - BioFire Diagnostics	ISO 9001 ISO 13485 MDSAP

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