Abstract
An overall risk management process in healthcare should involve the evaluating of potential risk related to medical devices and technology. The importance of this analysis is undelined by many legislative measures of both the Italian Country and the European Community. This article describes the importance of a medical devices vigilance system and the analysis that can be conducted to establish the baseline hazards associated with a device, evaluating its potential hazards. To improve patients safety, the risk analysis should include any risks associated with the manufacture and delivery of the device.
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