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Published in:
2014 | OriginalPaper | Chapter
Risk Analysis and Measurement Uncertainty in the Manufacturing Process of Medical Devices
Authors : P. E. Baru, N. M. Roman, C. Rusu
Published in: XIII Mediterranean Conference on Medical and Biological Engineering and Computing 2013
Publisher: Springer International Publishing
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This paper presents a new risk analysis methodology coming from the measuring process of the medical device characteristics. Thus, one can determine the acceptance criteria for the functioning parameters of the medical device undergoing trials in order to be introduced to the market. We point out the fact that the proposed methodology is complementary to the medical device certification process and provides a technical support for its quality assessment.