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Increase your understanding of the essential U.S. medical device regulations, including device classification, organizing pre-market notification 510(k), and planning and submitting a Pre-market approval (PMA). Enhance your knowledge of topics t...
... )( Section 1) Quarter: FALL 2022 Instructor Dan Modi, M.B.A., RAC, has 25 ... years' experience in Standards Certification, Regulatory Documentation and Design Control requirements for medical devices. Modi is certified ...