Theoretical Bases And Organization Of Medical Devices

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Theoretical Bases and Organization
Serious adverse event reports (encompass death, life-threatening events, hospitalization, disability, congenital anomalies, and/or required interventions, and disabilities) and recalls related to medical device are due to failures in the quality systems during the pre-market activities. The number of adverse event reports has increased dramatically; these post-market issues uncovered the failures in the quality systems such as design controls and production and process controls that could be a strong predictor for recall root cause. The number of complexity of medical devices has grown rapidly. In parallel, the medical device supply chain has become increasingly cost competitive and globalized. The quality systems that manage the evolving complexity of medical devices together with multiple layers of thousands of raw material, component, and sub-component suppliers, all of whom potentially impact final product quality and performance.
There are opportunities for improving quality in medical device industry without increasing quality cost by identifying the quality barriers. Quality improvements are hindered by challenges within the industry as well as with regulatory bodies. Medical devices are subject to a high degree of regulation, quality systems can become a principal of auditing and policing. If product quality is managed through inspection rather than design, the quality will become reactive. According to Deming 100%
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