Biomedical Design & Regulation

This subject has the following teaching availabilities in 2008:

For the purposes of considering request for Reasonable Adjustments under the Disability Standards for Education (Cwth 2005), and Student Support and Engagement Policy, academic requirements for this subject are articulated in the Subject Overview, Learning Outcomes, Assessment and Generic Skills sections of this entry.

It is University policy to take all reasonable steps to minimise the impact of disability upon academic study, and reasonable adjustments will be made to enhance a student's participation in the University's programs. Students who feel their disability may impact on meeting the requirements of this subject are encouraged to discuss this matter with a Faculty Student Adviser and Student Equity and Disability Support: http://services.unimelb.edu.au/disability

Product development including conceptualisation, design, development and testing protocols. The ethical standards to be met, and regulatory framework, for devices and/or therapeutic agents in Australia and overseas. Consideration of the technical, managerial, economic, financial, environmental and society factors impacting on the development of new device and/or therapeutic agent.

At the conclusion of this subject students should:

• Be able to describe the factors that contribute to the development of new devices or theraputic agent;
• Understand the ethics, standards, and regulations aplicable to the development of therapeutic devices and/or agents in Australia and overseas.

This subject is not available as a breadth subject.

At the end of this subject students should have an:

• Ability to communicate effectively,not only with engineers but also with the community at large;
• In depth technical competence in at least one engineering discipline;
• Ability to undertake problem identification formulation and solution;
• Ability to utilise a systems approach to design and operational performance;
• Ability to function effectively as an individual and in multi-disciplinary and multi-cultural teams, with the capacity to be a leader or manager as well as an effective team leader;
• Understanding of the social, cultural, global, and environmental responsibilities of the professional engineer, and the need for sustainable development.
• Understanding of the principles of sustainable design and development.