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Unit of study_
BMET5992: Regulatory Affairs in the Medical Industry
2025 unit information
Supply of medical devices, diagnostics and related therapeutic products is regulated in most jurisdictions, with sophisticated and complex regulatory regimes in all large economies. These regulations are applied both to manufacturers and designers and to biomedical engineers undertaking device custom manufacture or maintenance in clinical environments. This UoS will explore the different regulatory frameworks in the 'Global Harmonisation Task Force' group of jurisdictions (US, EU, Canada, Japan, Australia), as well as emerging regulatory practices in Asia and South America. Emphasis will be on the commonality of the underlying technical standards and the importance of sophisticated risk management approaches to compliance.
Unit details and rules
Managing faculty or University school:
Engineering
| Study level | Postgraduate |
|---|---|
| Academic unit | Biomedical Engineering |
| Credit points | 6 |
|
Prerequisites:
?
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None |
|---|---|
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Corequisites:
?
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None |
| Prohibitions:
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AMME4992 or AMME5992 |
| Assumed knowledge:
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MECH3921 or BMET3921 or AMME5921 or BMET5921 and 6 credit points of 1000-level Chemistry and 6 credit points of Biology units |
At the completion of this unit, you should be able to:
- LO1. define a timeline and meet deadlines for the completion of a complex project
- LO2. understand and adhere to standard medical practices and ethical requirements as part of a product formulation
- LO3. present findings of a design project in a concise fashion to peers
- LO4. formulate a biomedical product and adjust to suit specific requirements
- LO5. demonstrate a broad understanding of international regulatory requirements and the technical and engineering basis of these regulations as they relate to the practice of biomedical engineering in both industrial and clinical environments.
Unit availability
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The outline is published 2 weeks before the first day of teaching. You can look at previous outlines for a guide to the details of a unit.
| Session | MoA ? | Location | Outline ? |
|---|---|---|---|
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Semester 2 2025
|
Normal day | Camperdown/Darlington, Sydney |
Outline unavailable
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Modes of attendance (MoA)
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