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 unit 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.
through semester assessment (100%)
6cp of 1000-level Chemistry, and 6cp of Biology units
(AMME9901 OR MECH2901) AND (MECH3921 OR AMME5921)Prohibitions