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Unit of study_

Regulatory Affairs in the Medical Industry - BMET5992

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.

Classes
lectures

Assessment
through semester assessment (100%)

Assumed knowledge
6cp of 1000-level Chemistry, and 6cp of Biology units

Pre-requisites

(84 cp of BE units) or AMME5921 or BMET5921

Prohibitions

AMME4992 OR AMME5992

Details

Faculty: Engineering and Information Technologies

Semester 2

05 Aug 2019

Department/School: Biomedical Engineering
Study Mode: Normal (lecture/lab/tutorial) day
Census Date: 31 Aug 2019
Unit of study level: Fifth Year
Credit points: 6.0
EFTSL: 0.125
Available for study abroad and exchange: Yes
Faculty/department permission required? No
Location
Camperdown
Courses that offer this unit

Non-award/non-degree study If you wish to undertake one or more units of study (subjects) for your own interest but not towards a degree, you may enrol in single units as a non-award student. Cross-institutional study If you are from another Australian tertiary institution you may be permitted to undertake cross-institutional study in one or more units of study at the University of Sydney.

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