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Open Source Medical Devices – A visual Guide for Makers

An introduction to the regulations to design, commercialize and distribute an open source medical device in EU
A visual summary of things to consider for open source medical devices in the EU

CATEGORY

CERTIFICATION & LEGAL

TAGS

careablescertificationlegislationmakers

CREATORS

WeMake

Suggested skills and knowledge

No prior skills or knowledge.

Resources

Open source medical devices

pdf file

Aim of the resource

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.

How to use it

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

We are here to help you

Browse through the most frequent issues and questions.