The new RED directive about radio-electric equipment was published. It will be mandatory from June 2016. The new 2014/53/EU directive, of the European Parliament and of the Council, of the 16th of April 2014, defines the marketing rules for radio-electric equipment...
In March 2015, the FDA published a guide, written in question/answer form, intended to outline the use of electronic media, and the processes used to obtain electronic informed consent from participants (or their representatives) in a clinical investigation. This...
UDI System
Quality
Digital health
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Electrical devices
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