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Unit of study_

Regulatory Affairs in the Medical Industry - BMET5992

Year - 2020

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
Refer to the assessment table in the unit outline.

Assumed knowledge
MECH3921 OR BMET3921 OR AMME5921 OR BMET5921 and 6cp of 1000-level Chemistry and 6cp of Biology units

Prohibitions

AMME4992 OR AMME5992

Details

Faculty: Engineering

Semester 2

03 Aug 2020

Department/School: Biomedical Engineering
Study Mode: Normal (lecture/lab/tutorial) day
Census Date: 31 Aug 2020
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
More details
Unit of Study coordinator: Francis Manno
HECS Band: 2
Courses that offer this unit

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