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Regulatory Affairs in Medical Industry

AMME4992

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 of study details

Unit of study level: Honours

Credit points: 6

Commencing semesters: 2

Further unit of study information

Unit of study handbook: AMME4992

Costs and scholarships information: Costs and Scholarships

Final dates to withdraw from units of study: Census Dates

Available for study abroad and exchange: Yes

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