Capstone design

Specialized interdisciplinary program

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Program related to medical equipment approval

· Purpose: Nurture the competency to perform all processes required for licensing and approval of medical devices such as with the CE and FDA, coupled with providing the engineering and technical background for the workforce required by companies

· Regulation: Acquire more than 36 credits including specialized subjects, basic major and MEDICI common subjects

· Requirement for major related to medical device license and approval

Cooperating department Special subject Basic major MEDICI common subject
participation department 3 of 4 specialized subjects (9 credits) At least 1 subject in the coordinating department besides the primary major (3 credits) · Capstone design, field training subject (4 credits)
· More than 2 start-up subjects (6 credits)
· More than 1 elective liberal arts subject (basic engineering subject) (3 credits)

· Specialized subject

Type Subject name (1st term) Credit Subject name (2nd term) Credit
Specialized subject (4) FDA/CE MDD basis
Medical device design
3 · Medical device software validation
· Medical device quality management system
· Medical device overseas certificate overview
3
Unique subject for majors related to medical device license and approval

Major related to the medical industry

· Purpose: Nurture site-oriented human resources in the medical device industry with interdisciplinary major and knowledge

· Regulation: Achieve more than 36 credits including the converged subjects, basic major and MEDICI common subjects

· Requirement for completing major related to the medical industry

Cooperating department Special subject Basic major MEDICI common subject
LINC participation department At least 3 subjects including the (9 credits) At least 1 subject in the coordinating department besides the primary major (3 credits) · Capstone design, field training course (4 credits)
· More than 2 start-up subjects (6 credits)
· More than 1 elective liberal arts subject (basic engineering subject) (3 credits)

· Specialized subject

Type Subject name (1st term) Credit Subject name (2nd term) Credit
Converged subject (12 subjects) · Health environment engineering overview
· Medical material chemistry
· Health and medical policy
· Medical database
· Bio-material engineering
· Medical industry overview
3
3
3
3
3
3
· Medical packaging overview
· Medical mobile programming
· Medical business administration
· Medical engineering overview
· Medical industry and finance
· Plan and strategy of medical product industry
3
3
3
3
3
3
Unique subject for major related to medical industry license and approval