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.

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3 hour weekly lecture


Through semester assessment(100%)

Faculty/department permission required?


Unit of study rules

Prerequisites and assumed knowledge

MECH3921 and (MECH2901 or 6 credit points of Intermediate level Physiology)

Assumed knowledge: BIOL1003 or 6 credit points of junior biology CHEM1101 or 6 credit points of junior chemistry MECH2901 or 6 credit points of intermediate physiology or equivalent MECH3921

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