Product Risk Management Under ISO 14971:2007

Lincoln, John E.
November 2009
Journal of Validation Technology;Autumn2009, Vol. 15 Issue 4, p10
Academic Journal
The article discusses risk management in the context of medical devices. According to the International Organization for Standardization (ISO) 14971:2007, the use of medical device entails some degree of risk and the judgments relating to safety of the device are made by the manufacturer. The product life cycle, which includes its initial conception to disposal, should be considered when managing its risk. The development of a risk management plan defines the company systems and procedures. The plan must address commitment and involvement of senior management, as well as high level strategic considerations. Risk analysis, risk evaluation and acceptability and the probability of occurrence are all considered in the management process.


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