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ed273 replied to the topic "Predicate Devices and the 510(k) Process" – 1 month, 2 weeks ago
I believe the 510(k) pathway helps create devices without going through the Class III medical device process. Many companies try to avoid Class III because it takes time and money to be able to do all the testing and paperwork…. Read more»
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ed273 replied to the topic "Should AI-Based Medical Devices Require the Same Regulatory Approach as Traditional Medical Devices ?" – 1 month, 2 weeks ago
I believe like others have mentioned that AI based medical devices do not need to re-submit paperwork for every update. The company is liable for the updates and how it can effect their device. Companies should be required to maintain… Read more»
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ed273 replied to the topic "Pressure vs. Safety: A Project Manager’s Toughest Decision" – 2 months ago
A project manager is to balance the project timeline based on the projects needs and issues. The patients safety is always the first concern as there are many blocks if the problem is not solved. The main one is the… Read more»
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ed273 replied to the topic "Exceeding the budget" – 2 months ago
While, I have never been in a budget meeting before. I assume the higher ups decide what is the worth of this project to their portfolio and how much shareholder will this project give them. An example is if a… Read more»
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ed273 replied to the topic "Multiple Project Managers for one project" – 2 months ago
I have worked on a project that had only one project manager. The projects in my internship had always one project manager but also a project lead. As a our project manager could be managing mulitple projects therefore the project… Read more»
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ed273 replied to the topic "Co-Op / Internship Experience" – 2 months, 1 week ago
I believe having the experience of a co-op or internship really helps the applicant check out in the application pool. In my experience there was a difference between my resume having the co-op+ internship vs not having it done prior…. Read more»
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ed273 replied to the topic "Thoughts on BME degree, "a little of everything"" – 2 months, 1 week ago
I agree to an extent how Biomedical Engineering is a little bit of everything. As our first two years at NJIT, we had to take courses on each speciality to understand how each one works within the field. But, we… Read more»
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ed273 replied to the topic "Is AI going to control the medical Industry ?" – 2 months, 1 week ago
As many mentioned prior, AI will not “control” the medical industry but it will play a role in how jobs will be done. In my past internship, the managers wanted employees to use AI to help speed up researching, data… Read more»