PAÜ .:. Eğitim Öğretim Bilgi Sistemi

COURSE INFORMATION

Course Code	Course Title	L+P Hour	Semester	ECTS
BMM 529	QUALITY MANAGEMENT FOR MEDICAL DEVICES	3 + 0	2nd Semester	7,5

COURSE DESCRIPTION

Course Level	Master's Degree
Course Type	Elective
Course Objective	Knows the quality management processes for medical devices in all processes from production to post-sales recall. Knows what the CE mark is and how to apply.
Course Content	Knows the quality management processes for medical devices in all processes from production to post-sales recall. Knows what the CE mark is and how to apply.
Prerequisites	No the prerequisite of lesson.
Corequisite	No the corequisite of lesson.
Mode of Delivery	Face to Face

COURSE LEARNING OUTCOMES

1	Knows ISO 13485
2	Knows ISO 9001
3	Can analyze the needs
4	Knows CE marking and application processes

COURSE'S CONTRIBUTION TO PROGRAM

ECTS ALLOCATED BASED ON STUDENT WORKLOAD BY THE COURSE DESCRIPTION

Activities	Quantity	Duration (Hour)	Total Work Load (Hour)
Course Duration (14 weeks/theoric+practical)	14	3	42
Mid-terms	1	56	56
Final examination	1	56	56
Special Study Module (Student)	1	41	41
Total Work Load ECTS Credit of the Course			195 7,5

COURSE DETAILS

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L+P: Lecture and Practice
PQ: Program Learning Outcomes
LO: Course Learning Outcomes

Prospective Student