Product development in the biomedical area presents unique challenges that need to be addressed to efficiently satisfy strict regulatory requirements and to successfully advance products to approval for marketing. Biomedical engineers need a broad understanding of these challenges as the main components of product development are complex and interdependent. Development of good manufacturing and quality control processes, preclinical and clinical validation of product safety and efficacy, and regulatory filings, are each progressive and interdependent processes. This unit will provide a broad understanding of regulatory requirements for biomedical product development, with particular emphasis on the dependence of each component on the development of processes and control systems that conform to Good Manufacturing Practice. This unit assumes prior knowledge of cell biology and chemistry and builds on that foundation to elaborate on the important aspects of biomedical product development.
Through semester assessment (100%)
1000-level chemistry, 2000-level biology, and specific knowledge of cell biology at least at the 1000-level, and preferably at the 2000-level.
MECH2901 AND MECH3921