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Articles about entrepreneurship, traveling, business and life from Alvin Tai

09/04/2014
by Alvin
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Basic Design Control – Breaking down FDA’s guidance document – Part 1

FDA has a released guidance document for design controls located here: http://www.fda.gov/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm070627.htm It is a lengthy document that walks you through what is expected of medical device development. At it’s most basic form, the FDA recommends a cascading design process … Continue reading