Biomedical Eng Management & Regulations (BMEN90039)
Graduate courseworkPoints: 12.5On Campus (Parkville)
About this subject
Contact information
Semester 1
Overview
| Availability | Semester 1 |
|---|---|
| Fees | Look up fees |
This subject will cover key aspects of engineering management to help students prepare for working in the biomedical engineering industry including the processes and regulations of therapeutic goods.
It will focus on Biomedical Engineering Management, including the engineer and professional practice, the functions of professional societies; systems engineering and management processes of planning, organisation, leadership and control of human, physical and financial resources, biomedical engineering and quality management systems including ISO 9000 series requirements. This subject will also cover regulations, including risk management and international and Australian regulatory guidelines focusing on medical device regulations, classifications and standards. Also taught in this subject will be human clinical trials, regulation and ethics, design and evaluation of human clinical trials, requirements for post market monitoring, and medical device registries.
Intended learning outcomes
On completion of this subject, students should be able to:
- Evaluate the professional and ethical responsibilities of an engineer.
- Assess a broad range of managerial issues affecting the engineer.
- Assess the feasibility of engineering proposals using the principles of systems engineering and project management.
- Complete a profitability analysis of an engineering project or enterprise.
- Apply appropriate standards used in the design and maintenance of biomedical devices and the appropriate schedules in the distribution of therapeutic agents.
- Evaluate the process and regulations that are required to take a new medical device or a therapeutic agent to market.
- Evaluate the process of the post-market evaluation of therapeutic device/agents and incident reporting schemes.
- Define the ethics, standards and regulations applicable to the development of therapeutic devices and/or agents in Australia and overseas.
Generic skills
- Ability to communicate effectively, with the engineering team and with the community at large
- Ability to manage information and documentation
- Understanding of professional and ethical responsibilities, and commitment to them
- Ability to function effectively as an individual and in multidisciplinary and multicultural teams, as a team leader or manager as well as an effective team member.
- Ability to undertake problem identification, formulation and solution
- Ability to utilise a systems approach to design and operational performance
- Understanding of the principles of sustainable design and development
- Capacity for independent critical thought, rational inquiry and self-directed learning
Last updated: 4 March 2025
Eligibility and requirements
Prerequisites
| Code | Name | Teaching period | Credit Points |
|---|---|---|---|
| BMEN30008 | Biosystems Design | Semester 2 (On Campus - Parkville) |
12.5 |
Corequisites
None
Non-allowed subjects
BMEN90026 - Clinical Trials and Regulations
Inherent requirements (core participation requirements)
The University of Melbourne is committed to providing students with reasonable adjustments to assessment and participation under the Disability Standards for Education (2005), and the Assessment and Results Policy (MPF1326). Students are expected to meet the core participation requirements for their course. These can be viewed under Entry and Participation Requirements for the course outlines in the Handbook.
Further details on how to seek academic adjustments can be found on the Student Equity and Disability Support website: http://services.unimelb.edu.au/student-equity/home
Last updated: 4 March 2025
Assessment
| Description | Timing | Percentage |
|---|---|---|
Quizzes (total of 4 worth 5% each, through Canvas). Intended Learning Outcomes (ILOs) 1-8 are addressed in this assessment.
| From Week 2 to Week 12 | 20% |
Written report in groups of 3 or 4 . ILOs 1-8 are addressed in this assessment.
| Week 12 | 30% |
Oral presentation in groups of 3 or 4. ILOs 1-8 are addressed in this assessment.
| Week 11 | 10% |
Final exam. ILOs 1-8 are addressed in this assessment.
| During the examination period | 40% |
Last updated: 4 March 2025
Dates & times
- Semester 1
Principal coordinator Yasmin Blunck Coordinator Pip Karoly Mode of delivery On Campus (Parkville) Contact hours 12 x 2-hour lectures (total 24 hours), 11 x 3-hour workshops (33 hours) Total time commitment 200 hours Teaching period 3 March 2025 to 1 June 2025 Last self-enrol date 14 March 2025 Census date 31 March 2025 Last date to withdraw without fail 9 May 2025 Assessment period ends 27 June 2025 Semester 1 contact information
Time commitment details
200 hrs
What do these dates mean
Visit this webpage to find out about these key dates, including how they impact on:
- Your tuition fees, academic transcript and statements.
- And for Commonwealth Supported students, your:
- Student Learning Entitlement. This applies to all students enrolled in a Commonwealth Supported Place (CSP).
Subjects withdrawn after the census date (including up to the ‘last day to withdraw without fail’) count toward the Student Learning Entitlement.
Last updated: 4 March 2025
Further information
- Texts
- Subject notes
LEARNING AND TEACHING METHODS
The subject is delivered through lectures, workshop classes and group project work. Assessment is in the form of quizzes, a group workshop project (written report and presentation), and a final exam.INDICATIVE KEY LEARNING RESOURCES
Students are provided with lecture slides and documentation related to management and regulations, as well as important links via the TGA website.CAREERS / INDUSTRY LINKS
Exposure to management, regulations and standards in practice through several guest lectures. - Related Handbook entries
This subject contributes to the following:
Type Name Course Master of Engineering Specialisation (formal) Biomedical with Business Specialisation (formal) Biomedical - Available through the Community Access Program
About the Community Access Program (CAP)
This subject is available through the Community Access Program (also called Single Subject Studies) which allows you to enrol in single subjects offered by the University of Melbourne, without the commitment required to complete a whole degree.
Please note Single Subject Studies via Community Access Program is not available to student visa holders or applicants
Entry requirements including prerequisites may apply. Please refer to the CAP applications page for further information.
- Available to Study Abroad and/or Study Exchange Students
Last updated: 4 March 2025