Senior Consultant and Head of DepartmentWomen’s AnaesthesiaKK Women’s and Children’s Hospital
Associate Professor Sng Ban Leong is the Head and Senior Consultant at the Department of Women’s Anaesthesia, KK Women’s and Children’s Hospital (KKH).
He is also an Associate Professor and the Academic Vice-Chair (Research) of the Anaesthesiology and Perioperative Sciences Academic Clinical Program at the Singhealth Duke-NUS Academic Medical Centre. He is an experienced clinician researcher with in-depth experience and knowledge in conducting medical device clinical trials.
He has obtained several National Grants including the NMRC Clinician Scientist Award, NMRC Transition Award, NMRC Clinical Trials Grant, NHIC-I2D and I2I Grants. The novel epidural delivery system developed by his team with industry partner support, has been used to deliver routine labour epidural pain relief in KKH delivery suite.
Presentation Title
Medical Device Trial: Ethical and Regulatory Considerations
One of the essential step in development of medical device is pre-market clinical evaluation. This involves recruiting human subjects to test on the intended device. Conducting an ethical medical device trial requires not only informed consent, but also a coherent framework drawing on the collaboration between clinicians, research coordinators, ethical/regulatory boards, hospital biomechanical engineers, industry collaborators and other stakeholders relevant to research with human subjects and the use of medical devices. Here we will discuss about requirements on conducting a medical device trial in a systematic manner: grant funding, relevant ethical and regulatory approvals, risk management, data management, monitoring and documentation.
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