How is the medical device risk evaluation calculated?

You can go to study YY/T0316-2016 risk management standard.

Risk = probability * severity, the 2 indicators of risk are probability, severity, and the relationship is multiplication.

The standard recommended risk evaluation criteria is a 5X5 matrix, that is to say, the standard recommended probability is divided into 5 levels, severity is divided into 5 levels, but some companies are willing to be divided into 4x6 matrix, especially years ago some templates is such a customary practice.

The judgment of probability and severity certainly can not be subjective, but a certain degree of the development process of new products is indeed estimated.

The following seven methods of estimation are commonly used: ? -? Using relevant historical data;? -? Using analytical methods or simulation techniques to predict probabilities;? -? Utilizing experimental data;? -? Reliability estimation;? -(c) reliability estimation; (d) reliability estimation; (e) reliability estimation. Production data (b) The use of post-production information; - (c) The use of test data. Post-production information -? Use of expert judgment.

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