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.
|Academic unit||Biomedical Engineering|
|MECH2901 OR BMET2901|
|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:
Unit outlines will be available 2 weeks before the first day of teaching for the relevant session.
Key dates through the academic year, including teaching periods, census, payment deadlines and exams.
Enrolment, course planning, fees, graduation, support services, student IT
Code of Conduct for Students, Conditions of Enrollment, University Privacy Statement, Academic Integrity
Academic appeals process, special consideration, rules and guidelines, advice and support
Policy register, policy search
Scholarships, interest free loans, bursaries, money management
Learning Centre, faculty and school programs, Library, online resources
Student Centre, counselling & psychological services, University Health Service, general health and wellbeing