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  • dag56 replied to the topic Benefits of this course in the forum Project Management Process and Medical Device Development 8 years, 1 month ago

    I 100% agree with the two previous comments that this course is by far the most useful and applicable course I have taken here at NJIT. Before this course, I only had a brief background of what the FDA was and all the different area it regulates from Dr. Collins 672 Biomaterials class along with personal research. Now, I am starting to realize all the details, steps, and processes that are implemented in a successful medical device setting. I view this information as generally more useful in the industrial setting than other core classes because every medical device company has to follow these strict guidelines imposed by the FDA. Not every company will require such a broad range of specialty skills such as signal processing, the details of tissue engineering, or computer modeling (although knowing them can’t hurt).

    My experience applying the knowledge of the FDA I have learned in this class to industry has also been very beneficial. Because I hold an undergraduate degree in biochemistry, I thought I had a disadvantage when applying to BME internships/ jobs these past few months. However, with my growing knowledge of the FDA regulations along with the steps to validation and verification, I was able to thoroughly impress the interviewers when they asked about FDA related questions. In the end, I would have to credit Dr. Simon’s class with being one of the main reasons I recently received my job offer.