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Unit of study_

BMET5992: Regulatory Affairs in the Medical Industry

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.

Code BMET5992
Academic unit Biomedical Engineering
Credit points 6
AMME4992 OR AMME5992
Assumed knowledge:
MECH3921 OR BMET3921 OR AMME5921 OR BMET5921 and 6cp of 1000-level Chemistry and 6cp 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 outlines

Unit outlines will be available 1 week before the first day of teaching for the relevant session.