Module 19: Regulation of In Vitro Diagnostic Medical Devices

13/04/2023

Scientific Validity

 Qarad Academy “Scientific Validity Reports”

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Analytical Performance The ability of a device or test to accurately measure what it is supposed to measure time and time again • Analytical performance shall always be demonstrated on the basis of analytical performance studies. – Assay specific; – Trueness to be established versus certified reference materials or measurements, if possible; – Comparative methods; – If not, comparison with general standard practice; – Performance characteristics to be tested listed in Annex I Chapter II 9.1.

Analytical Performance

• Analytical performance shall be demonstrated and documented in the analytical performance report .

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