University of Technology Sydney

41161 Biomedical Industry Frameworks

6cp; 5hpw (lecture and tutorials); all students are encouraged to attend the tutorials in their teams, these tutorials further strengthen students' understanding of the regulatory environment



This subject introduces students to the various frameworks, procedures and regulations that are commonplace within the biotech/medical device industry. Students learn to identify standard mechanisms associated with quality systems, regulatory affairs, design processes and risk analyses essential to operating within the industry. Further, they gain skills to apply the relevant tools within each of these areas. Students gain an understanding of regulatory environments both within Australia and overseas. This subject provides a foundation for students to enter the regulated environment of biotech businesses and to operate from an informed position within them.

Typical availability

Autumn session, City campus

Detailed subject description.

Access conditions

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