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jlw23 replied to the topic Experience with Design Control in the forum Introduction to Project Management 7 years, 2 months ago
In worked on a med-device for soft bone injuries that that I built with a group of 4 people. The design was based on a modification to a cam walker boot. The design was already similar in physical trails to the boot, however we automated various function that brought together features that would usually be separate but needed in cases with soft bone injuries. The design was all mechanical and electrical. Most of the automation was done via coding in a microcontroller. The added features all came with a different part that we had to test for safety and efficacy. All of our design controls had to meet the costumer needs. The specification had to distinguish all the components and its function, it even included the coding and the electronic outline. I work with the mechanical aspects of the design and had to calibrate the sensors as well as insure all reading were mathematically correct.
Our roles were not all on physical design. Some members of the groups focused on the materials and the paper work. The market researched shoed that our device was a bit unique and would be considered a class II device due to the additional features.