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Unit of study_

Regulatory Affairs in the Medical Industry - AMME5992

Year - 2018

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.

Classes
Lectures

Assessment
through semester assessment (100%)

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

Pre-requisites

(AMME9901 OR MECH2901) AND (MECH3921 OR AMME5921)

Prohibitions

AMME4992

Details

Faculty: Engineering and Information Technologies

Semester 2

30 Jul 2018

Department/School: Aerospace, Mechanical and Mechatronic
Study Mode: Normal (lecture/lab/tutorial) day
Census Date: 31 Aug 2018
Unit of study level: Postgraduate
Credit points: 6.0
EFTSL: 0.125
Available for study abroad and exchange: Yes
Faculty/department permission required? Yes
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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