This unit of study will provide students with the knowledge and skills to understand how medical devices are researched, developed and regulated. The unit will cover traditional medical devices, in vitro diagnostics, digital therapeutics and software-as-a-medical-device products. The regulatory requirements for manufacturing, pre-clinical testing, and clinical testing will be discussed. Finally, the unit will examine the regulatory requirements for registration of these types of products.
Unit details and rules
Academic unit | Pharmacy |
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Credit points | 6 |
Prerequisites
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None |
Corequisites
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None |
Prohibitions
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PCOL5103 |
Assumed knowledge
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None |
Available to study abroad and exchange students | Yes |
Teaching staff
Coordinator | Orin Chisholm, orin.chisholm@sydney.edu.au |
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Lecturer(s) | Philip Kwok, philip.kwok@sydney.edu.au |
Tutor(s) | James Morrison, james.morrison@sydney.edu.au |