Risk management process and CE marking of software as MD

Computers and software are more and more used for the scope of the clinical data analysis and for the patient treatment control. At the same time a lot of electrical medical device are used together for increase their function and to expand their performance, in a logic of a system thought as a single unit. This integration may bring new hazards, created by functional supplementary connections and by those linked to software. An appropriate design approach, including a deep and integrated risk analysis, must then be performed. A wide legislative and technical standard context has to be considered to achieve a CE marked (i.e. "ready-for-the-market") product. In this study main international technical standard related both to software and to MD are taken into account to define a sort of guideline to software related CE marking. © 2010 International Federation for Medical and Biological Engineering.