Biomedical Design & Regulation

Subject BMEN40004 (2010)

Note: This is an archived Handbook entry from 2010.

Credit Points: 12.50
Level: 4 (Undergraduate)
Dates & Locations:

This subject has the following teaching availabilities in 2010:

Semester 2, Parkville - Taught on campus.
Pre-teaching Period Start not applicable
Teaching Period not applicable
Assessment Period End not applicable
Last date to Self-Enrol not applicable
Census Date not applicable
Last date to Withdraw without fail not applicable

Timetable can be viewed here. For information about these dates, click here.
Time Commitment: Contact Hours: Thirty-six hours of lectures, 12 hours of tutorials, 12 hours of project work.
Total Time Commitment: 120 hours per semester
Prerequisites: Both subjects are required.
Study Period Commencement:
Credit Points:
Not offered in 2010
Corequisites: None
Recommended Background Knowledge: None
Non Allowed Subjects: None
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



Dr Emmanuel Koumoundouros


Melbourne School of Engineering
Ground Floor
Old Engineering Building #173
The University of Melbourne VIC 3010 AUSTRALIA

General telephone enquiries
+ 61 3 8344 6703
+ 61 3 8344 6507

+ 61 3 9349 2182
+ 61 3 8344 7707

Subject Overview:

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 therapeutic agent
  • Understand the ethics, standards, and regulations applicable to the development of therapeutic devices and/or agents in Australia and overseas
  • One 3-hour examination (60%)
  • Assignments/reports (40%)
Prescribed Texts: N/A
Breadth Options:

This subject is not available as a breadth subject.

Fees Information: Subject EFTSL, Level, Discipline & Census Date
Generic Skills:

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.
Notes: Subject is offered for the last time in 2010
Related Course(s): Bachelor of Engineering (Biomedical) Biomechanics
Bachelor of Engineering (Biomedical)Biocellular
Bachelor of Engineering (Biomedical)Bioinformatics
Bachelor of Engineering (Biomedical)Biosignals

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