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-forthe- 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.