Orgotech

During my senior year of my undergrad, my colleague and I decided to tackle an issue that affects patients that undergo Dialysis/ECMO machines. The largest problem these patients face are potential clot formations that could lead to strokes or heart attacks. Our idea was to design a method of detecting clots that form or travel through the tubing of the Dialysis or ECMO machines using pressure sensors so that anti-clotting drugs can be administered early to break down the clot.

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We were also tasked to determine all of the components that would go into turning our product into a small start-up. This include matching the FDA and ISO-9001 regulations to our device to organizing the structure of our company and determining the financials after the first year of operations. This was a very valuable experience because I learned all about the time and work that goes into designing a device and using it to try to start a company.

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The document to the right is a copy of our complete Quality Manual.

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