Risk analysis: a standard approach? (Part I)

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.