title: Risk analysis: a standard approach? (Part I).
abstract: The European Medical Device Directive (MDD) requires risk analysis to be conducted for all classes of devices. Many companies lack experience in conducting formal risk-analysis studies. To assist companies in complying with the Directive, a European standard on risk analysis is being developed. Part I of this two-part article will discuss the MDD requirements for risk analysis, the approach taken by the draft standard, and some alternative methods that some companies are using to generate risk-analysis data and information. Part II will discuss the contents of the draft standard in more detail.
authors.affiliation: Donawa and Associates Ltd., Rome, Italy.
authors.forename: M E
authors.initials: ME
authors.lastname: Donawa
mesh_terms: D003257:Consumer Product Safety; D004869:Equipment Safety; D004864:Equipment and Supplies / Q000009:adverse effects / Q000145:classification / Q000592:standards*; D005060:Europe; D017408:Guidelines as Topic; D006801:Humans; D008422:Materials Testing / Q000592:standards*; D019736:Prostheses and Implants / Q000009:adverse effects / Q000145:classification / Q000592:standards*; D018570:Risk Assessment