Medical Product Innovator
As an aspiring regulatory engineer, I have taken responsibility for all the regulatory considerations in the projects I have been apart of. I have expansive knowledge of many of the FDA databases and am eager to learn more. I am fascinated by this part of medical product development because you get to learn about all of the aspects of the project you are organizing for submission!
Classification
I have spent a lot of time understanding what classifies a medical device as class I,II or III as well as low or high risk. I am familiar with all the submission types, 510(K), PMA, de novo, HDE and what all they entail. I have developed mock submissions using verbiage typically used for the projects I have been apart of.
design control
I understand the Quality Management System very well and know all the steps required for supporting documents for FDA submission. For my device, The Biopsy PolyGuide, the final deliverable was a completed Design History File.
maude/medsun
