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medical devices are designed, tested and placed on the market in a highly regulated environment. Wearable sensors are crucial components of various medical devices: design and validation of wearable sensors, if managed according to international standards, can foster innovation while respecting regulatory requirements. Material and methods: the purpose of this paper is to take into consideration the upcoming EU Medical Device Regulation 2017/245 and the current and future IEC and ISO standardsdoi:10.20944/preprints201904.0265.v1 fatcat:l3qroquj7zaalhmaejoscmpq2y