Note: This is an archived Handbook entry from 2014.
|Dates & Locations:|| |
This subject is not offered in 2014.
|Time Commitment:||Contact Hours: 48 hours |
Total Time Commitment:
The prerequisite for this subject is:
Study Period Commencement:
Any equivalent design subject
Admission into the Master of Biomedical Engineering (745BM)
|Recommended Background Knowledge:|| |
|Non Allowed Subjects:|
|Core Participation Requirements:||
For the purposes of considering request for Reasonable Adjustments under the Disability Standards for Education (Cwth 2005), and Students Experiencing Academic Disadvantage Policy, academic requirements for this subject are articulated in the Subject Description, Subject Objectives, Generic Skills and Assessment Requirements of this entry. The University is dedicated to provide support to those with special requirements. Further details on the disability support scheme can be found at the Disability Liaison Unit website: http://www.services.unimelb.edu.au/disability/
Assoc Prof David Grayden
This subject covers biomedical product development including conceptualisation, design control, development and testing protocols, as well as the ethical standards to be met, and regulatory framework, for devices and/or therapeutic agents in Australia and overseas. Also considered are the technical, managerial, economic, financial, environmental and societal factors impacting on the development of a new device and/or therapeutic agent.
Risk Management – Australian regulatory guidelines for medical devices and ISO9000 series of standards
Design Control Processes - Design and development planning, Design input, Design control, Design output, Design review, and Design verification
Design Control of Medical Devices – the regulations, classifications and standard of Medical Devices. In-particular AS3200 series of standards and AS3551 standard;
Ethical standards – can a sponsor place a Therapeutic Device in the market without declaring that it is a therapeutic?
Drug Regulation in Australia – The Baume Report and the long road to the Pharmaceutical Market
International Drug Regulation – Global Regulation and Harmonisation of format of processes, Data, Evaluation reports, Decisions, Clinical Trials and Good Clinical Practices.
Institutional Structures, Product Information and Guidelines – Clinical trials notification schemes, human ethics, chemical, synthesis and property drug information, and drug guidelines.
These Medical Device topics are complemented by exposure to the Medical Devices in the Clinical Workshops and use of industry standard engineering software tools for design in the laboratory
INTENDED LEARNING OUTCOMES (ILO)
Having completed this unit the student is expected to:
Intended Learning Outcomes (ILOs) 1, 3-5 are assessed in the final written examination and the mid-semester test. ILOs 1-5 are assessed in the submitted project reports.
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|Breadth Options:|| |
This subject is not available as a breadth subject.
|Fees Information:||Subject EFTSL, Level, Discipline & Census Date|
LEARNING AND TEACHING METHODS
The subject is delivered through lectures, electronic resources; workshop classes that combine both tutorial and hands-on laboratory activities and site visits for the clinical workshops where students apply the theory.
INDICATIVE KEY LEARNING RESOURCES
Lectures, Electronic resources, Professional instruction, and Site visits
CAREERS / INDUSTRY LINKS
Exposure to industry and industry participation is achieved by visits to, and guest lecturers from, a selection of the following sites: Royal Melbourne Hospital, Austin Health Heidelberg, Nucleus Network Alfred Hospital, St Vincent’s Hospital Melbourne.
Bachelor of Engineering (Biomedical)Biocellular |
Bachelor of Engineering (Biomedical)Biosignals
Master of Biomedical Engineering
Master of Engineering (Biomedical) |
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