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A holistic approach to integrating the clinical risk profile of in-vitro diagnostic medical devices
Many varieties of In-Vitro Diagnostic (IVD) Medical Devices exist to diagnose and monitor some of the world’s most prevalent diseases. The ability to diagnose and monitor illnesses is imperative to the survival of those affected by them. Faults in the device may lead to discrepant, or no results, and will influence the diagnosis and likelihood of the patient to manage their illness. This thesis outlines a quantitative method to achieve a clinically relevant baseline of expected performance of an IVD medical device. The baseline data represents the probability associated with the clinical impact to the intended population after a failure in the system has occurred. The comparison of real-time data to the projected baseline can be used holistically throughout a company to influence three of the key elements of Total Quality Management (TQM): customer focus, continuous improvement, and teamwork.