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CERTIFICATION & LEGAL
No prior skills or knowledge.
Open source medical devices
This useful document visually summarizes - step-by-step - the procedures beyond medical assistive devices, as defined by EU legislation, and their certification. The guide has been developed by WeMake in collaboration with UBORA researchers, Carmelo De Maria and Licia Di PIetro, within the DSI4EU project, funded by EU Commission.
It aims to:
. classify the type of solutions developed by makers or designers;
. understand the functions and purposes of the developed solutions;
. identify the class of risk;
. determine the assessment procedure according to the class of risks.
This is a useful tool for those involved in making careables for job, in their free time or within contexts such as meetups, hackathons, summer schools: makers, designers, engineers and any other individuals with technical/practical skills. Steps: Download it / Read it / Use it or share it
Browse through the most frequent issues and questions.