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Unit of study_

BMET3990: Biomedical Product Development

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 UoS 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 UoS assumes prior knowledge of cell biology and chemistry and builds on that foundation to elaborate on the important aspects of biomedical product development.

Code BMET3990
Academic unit Biomedical Engineering
Credit points 6
Prerequisites:
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MECH2901 or BMET2901 or [MEDS2005 and (MEDS2001 or PHSI2007)]
Corequisites:
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None
Prohibitions:
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AMME4990 or BMET4990 or AMME9990 or BMET9990
Assumed knowledge:
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1000-level chemistry, 2000-level biology, and specific knowledge of cell biology at least at the 1000-level, and preferably at the 2000-level

At the completion of this unit, you should be able to:

  • LO1. Demonstrate a broad understanding of biomedical product development within the regulatory framework
  • LO2. Identify and understand the proceses and quality systems that satisfy the internationally agreed standards for good manufacturing practice
  • LO3. Demonstrate expertise in working in a team environment to develop a medical product concept and plan in conformity with regulatory guidelines
  • LO4. Understand and describe how previous drug and device failures have guided the evolution of the current drug and device delivery testing regimes.