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My team and I identified and selected a commercially available medical device as a benchmark for review. We prepared a 10 to 15 page technical engineering report, where we reviewed and discuss the benchmark device within the framework of the course topics including:
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- Need Identification and Problem Definition
- Anatomy and Physiology
- Patents and Intellectual Property
- Performance Requirements
- Regulatory Requirements
- Biomaterials and Materials Considerations
I worked on the researching Regulatory Requirements for our device and adding recommendations to improve the device using my team’s research on the other topics.
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