Module 19: Regulation of In Vitro Diagnostic Medical Devices

13/04/2023

Analyte

Lab results with own assay

Scientific Literature

Analytical Performance

Scientific Validity

APR

SVR

PER

IVD Device

Clinical Condition

Clinical Performance

CPR

Clinical Validation studies or

Published Literature with own assay Or published routine diagnostic testing

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Step 1: Plan

www.qarad.com

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