An interactive event on 'Regulation and Approval process of medical devices: need and context'.

December 21, 2022

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In this talk, Dr. Mrinal Kanti Musib will touch on the two years long, graduate-cert programs, Medical Device Regulatory Affairs (MDRA) and Advanced Medical Device Regulations (AMDR) offered at NUS, which are intended to train both early and mid-career professionals. He serves as the program coordinator/resource person for both programs. He also teaches a graduate-level module, BN5208-Biomedical Quality, and Regulatory Systems. In this talk, he will discuss some salient issues relating to why medical devices (implants in particular) should be regulated and their significance. He will also briefly discuss FDA-risk-based classification, what may happen in the absence of a robust and transparent approval process, and why governments should allocate more resources to ensure the long-term safety and performance of such devices.

Dr. Mrinal Kanti Musib

Senior Lecturer, Department of Biomedical Engineering, National University of Singapore (NUS)

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