Biomedical Eng Management & Regulations

This subject will cover key aspects of engineering management to help students prepare for working in the biomedical engineering industry including the processes and regulations of therapeutic goods. It will focus on Biomedical Engineering Management, including the engineer and professional practice, the functions of professional societies; systems engineering and management processes of planning, organisation, leadership and control of human, physical and financial resources, biomedical engineering and quality management systems including ISO 9000 series requirements. This subject will also cover regulations, including risk management and international and Australian regulatory guidelines focusing on medical device regulations, classifications and standards. Also taught in this subject will be human clinical trials, regulation and ethics, design and evaluation of human clinical trials, requirements for post market monitoring, and medical device registries.

学习生物医学工程项目管理与行业法规。

• 1Evaluate the professional and ethical responsibilities of an engineer.
• 2Assess a broad range of managerial issues affecting the engineer.
• 3Assess the feasibility of engineering proposals using the principles of systems engineering and project management.
• 4Complete a profitability analysis of an engineering project or enterprise.
• 5Apply appropriate standards used in the design and maintenance of biomedical devices and the appropriate schedules in the distribution of therapeutic agents.
• 6Evaluate the process and regulations that are required to take a new medical device or a therapeutic agent to market.
• 7Evaluate the process of the post-market evaluation of therapeutic device/agents and incident reporting schemes.
• 8Define the ethics, standards and regulations applicable to the development of therapeutic devices and/or agents in Australia and overseas.