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bnb6 replied to the topic Device Class Confusion in the forum Project Management Process and Medical Device Development 7 years ago
This year my senior capstone project focuses on the attachment between a polyethylene component and tibial implant used in total ankle replacements. There is currently two piece total ankle replacements on the market, so our device would be classified as class 2. However this is still a lot of testing for our team to complete in capstone to show proof of concept. If this design is used in industry it would follow a class two device protocol.