I3CGLOBAL QARA Team MDR CE MARKING June 10, 2020

Intended Users and Intended Patient Populations

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I3CGLOBAL QARA Team MDR CE MARKING June 10, 2020

Intended Use vs Indications of Use

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I3CGLOBAL QARA Team FDA 510k June 3, 2020

US FDA Pre Market Submissions

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I3CGLOBAL QARA Team MDR CE MARKING May 18, 2020

European Medical Device Nomenclature (EMDN)

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I3CGLOBAL QARA Team MDR CE MARKING May 8, 2020

Product Conformity Verification

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I3CGLOBAL QARA Team MDR CE MARKING May 8, 2020

EU Type Examination Certificate

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I3CGLOBAL QARA Team MDR CE MARKING May 7, 2020

EU Technical Documentation Assessment Certificate

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I3CGLOBAL QARA Team ISO 13485 May 6, 2020

EU Quality Management System Certificate

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I3CGLOBAL QARA Team MDR CE MARKING May 4, 2020

Sterility Assurance Level FDA (SAL)

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