Programme overview
Main Subject
Anatomy and Physiology
Degree
PhD
Study Level
PHD
Study Mode
On Campus
- Understand and apply 21 CFR 820.30 (Design Control) and ISO 13485 7.3 (Design and Development) in the design and development of medical devices
- Develop a business strategy, identify potential funding sources, and outline a business model for a medical device startup company
- Understand how medical devices interact with complex biological systems
- Develop a medical device using various design tools and methods
- Develop and implement a regulatory strategy for FDA submission
Ph.D. students in the bioInnovate track must successfully complete the bioInnovate course requirements, as well as those required for the Ph.D. degree program. This includes passing the bioInnovate written qualifying exam. The purpose of the qualifying exam in this track is to verify students’ proficiency in the fundamental principles of Biomedical Engineering, regulatory compliance, medical device innovation, and translational strategy development. Students should take the exam in their second year of study. Although the specific content of the exam changes each year, approximately 50% of the exam covers material from the Bioinnovate track fundamentals courses, and the remaining 50% from student elective classes.
Please refer to the latest Graduate handbook for more information on requirements for bioInnovate courses and graduate degree programs.
Programme overview
Main Subject
Anatomy and Physiology
Degree
PhD
Study Level
PHD
Study Mode
On Campus
- Understand and apply 21 CFR 820.30 (Design Control) and ISO 13485 7.3 (Design and Development) in the design and development of medical devices
- Develop a business strategy, identify potential funding sources, and outline a business model for a medical device startup company
- Understand how medical devices interact with complex biological systems
- Develop a medical device using various design tools and methods
- Develop and implement a regulatory strategy for FDA submission
Ph.D. students in the bioInnovate track must successfully complete the bioInnovate course requirements, as well as those required for the Ph.D. degree program. This includes passing the bioInnovate written qualifying exam. The purpose of the qualifying exam in this track is to verify students’ proficiency in the fundamental principles of Biomedical Engineering, regulatory compliance, medical device innovation, and translational strategy development. Students should take the exam in their second year of study. Although the specific content of the exam changes each year, approximately 50% of the exam covers material from the Bioinnovate track fundamentals courses, and the remaining 50% from student elective classes.
Please refer to the latest Graduate handbook for more information on requirements for bioInnovate courses and graduate degree programs.
Admission Requirements
- Candidates are required to submit references or letter(s) of recommendation for acceptance
- Candidates are required to submit an essay(s) for acceptance
Tuition fees
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