This is my second course with dr. Simon. I previously have taken Medical Devices Development (BME684). The amount of information I learned about the paperwork and all the requirements to carry a project in real life. This has encouraged me take this course as well. Although there is some overlap between both courses, I keep learning new and more definition about projects and the industry overall. For someone with a limited experience like me, I feel rich with the information I feel about the industry from this course and the one before. I also agree with all who mentioned the importance of knowing about FDA and regulations, our industry requires a good knowledge of it and this course truly helps.