OpenFlexure: What It Takes to get Medical Device Certification for an Open Source Microscope

Using off-the-shelf components and 3D-printed parts it can be build for around 400 euros, bringing automated digital microscopy to underserved communities. The NGI Zero funded development focuses on collecting and sharing of data to facilitate remote second opinions. So we are working on tooling both around the data collection and the data sharing so doctors can simply get on a video call, bring up an image of a biopsy and discuss the diagnosis. There are people who give workshops on how to build and use the microscope in countries like Sweden, Ghana, Scotland, Senegal and Ukraine. We do want local manufacturers to be able to make profit but we don't want centralized IP and us making a huge profit in the UK. The best port of call is the forum, just reach out and tell us why you're interested in the in the project.