Risk analysis: a standard approach? (Part II).
Part I of this article noted that the European Medical Device Directive requires risk analysis to be conducted for all classes of devices. The article also pointed out that a risk analysis standard is being developed to assist companies in complying with this requirement. Part II will discuss the contents of the draft standard, some issues that should be considered in meeting the standard, and the usefulness of failure analysis techniques.
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D004869:Equipment Safety; D004864:Equipment and Supplies / Q000009:adverse effects* / Q000592:standards*; D005060:Europe; D017408:Guidelines as Topic; D006801:Humans; D008422:Materials Testing; D018570:Risk Assessment