Clinical Design and Evaluation of Medical Devices (Synchronous e-learning)

About This Course

"This course provides a comprehensive review of clinical design and evaluation for medical devices. It focuses on the roles of clinical evaluations in product development including the roles of various pivotal trials and the postmarket study. The students will learn to design a clinical study taking into consideration the various aspects of the study like the ethics, treatment regimen, study population, the product effectiveness and safety endpoints. In addition, the course will guide the students through a rigorous and systematic review of and integration of clinical data follow by the drafting of a clinical evaluation report.
1. To gain an understanding of the general principles of clinical design, evaluation and strategy
2. To understand the key elements and terms of clinical study design and evaluation, including various statistical tools available
3. To be able to perform systematic review of and integration of clinical data and the drafting of a clinical evaluation report
4. To understand the clinical investigations application process and reimbursement
5. Be conversant in individual and group presentation and report writing
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