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  • alexandrabuga replied to the topic AMDD in the forum Clinical Trials for Medical Devices 7 years, 5 months ago

    I agree that MDD and AMDD have been integral in providing me the necessary platform not only for my other classes, but for my career. I currently work on the business end, but I am new to the medical device development process from Design to Manufacturing. I think these courses have provided me very valuable information regarding QC and Regulatory not just in the US, but Europe. Having a better understanding of all these processes, and how detailed this work can be has been eye opening. For one of my robotic devices we contracted the work develop a clinical functional prototype and they sent me so many documents and the gantt chart was so incredibly detailed that it felt like it was information overload and I couldn’t appreciate why they had all of this documentation. Now understanding the DHF and regulatory requirements, I completely understand and will make sure any CROs we use will follow these requirements.

    I think it would be great if NJIT included more courses like this in their curriculum.