Glia – High-quality low-cost open source medical hardware
They are certainly working designs and products, but I am not sure there are actually medical devices[0].<p>The research (self) validation [1] talk about similar performances than an existing product.<p>However, it does not talk about bio compatibility of the material used, potential contamination during manufacturing process, what kind of disinfectants can be used on the product, what is the operating range in terms of pressure, temperature, humidity, etc<p>A proper medical device manufacturer is also supposed to have a complaint handling unit, to raise and analyze every adverse effect on the field, and report to regulatory bodies the worst hazardous case in a limited time frame, be able to do recall and so on.<p>So I believe that this coming from the Gaza strip is a real boon because you don't have any other choice, but it does not mean that you could translate that model everywhere in the world.<p>Edit :<p>it seems this is registered as a Class 1 medical device in Canada, so it is possible that all my previous point have been addressed (still I am not quite sure how you can validate only a design without the manufacturing/shipping part) I am working on a Class 3 device so it is possible I am more paranoid that I should be...<p>>> In Canada, it is produced by Glia as a Class I device. Glia holds a Medical Device Establishment License from Health Canada.<p>I am not sure how you could pass an audit if your documentation contains "Lorem Ipsum" [2]<p>[0] The homepage mentions medical Hardware, but this page <a href="https://docs.glia.org/" rel="nofollow">https://docs.glia.org/</a> still talks about medical device<p>[1] <a href="https://glia.org/stethoscope/" rel="nofollow">https://glia.org/stethoscope/</a><p>[2] <a href="https://docs.glia.org/docs/stethoscope/manufacturing/" rel="nofollow">https://docs.glia.org/docs/stethoscope/manufacturing/</a>