1. FIRST CYCLE - BACHELOR'S DEGREE
  2. FACULTY OF PHYSIOTHERAPY AND REHABILITATION
  3. PHYSICAL THERAPY AND REHABILITATION DEPARTMENT
  4. 285 PHYSIOTHERAPY AND REHABILITATION
Course Information Course Learning Outcomes Course's Contribution To Program ECTS Workload Course Details
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COURSE INFORMATION
Course CodeCourse TitleL+P HourSemesterECTS
MAIM 413MEDICAL DEVICE LEGAL REGULATIONS AND PROCESSES1 + 08th Semester1

COURSE DESCRIPTION
Course Level Bachelor's Degree
Course Type Compulsory
Course Objective The aim of this course is to introduce the place of medical devices in health policies and the regulations that medical device manufacturers have to comply with.
Course Content Course; It covers the recommendations, management policies and decisions of the World Health Organization regarding medical devices for the world and Turkey, the Medical Device Regulation, the Quality Management System Principles for Medical Devices and similar legal regulations and regulations that medical device manufacturers and importers have to comply with.
Prerequisites No the prerequisite of lesson.
Corequisite No the corequisite of lesson.
Mode of Delivery Face to Face

COURSE LEARNING OUTCOMES
1Students who successfully complete this course will be able to define and classify medical devices.
2Students who successfully complete this course will be able to explain medical device labels and medical device identification system.
3Students who successfully complete this course will be able to evaluate their CE Technical files.
4Students who successfully complete this course will be able to discuss the place of medical devices in health policies in the world and in Turkey.
5Students who successfully complete this course will be able to define priorities for innovation in medical devices.

COURSE'S CONTRIBUTION TO PROGRAM
Data not found.

ECTS ALLOCATED BASED ON STUDENT WORKLOAD BY THE COURSE DESCRIPTION
ActivitiesQuantityDuration (Hour)Total Work Load (Hour)
Course Duration (14 weeks/theoric+practical)14114
Mid-terms155
Final examination177
Total Work Load

ECTS Credit of the Course





26

1
COURSE DETAILS
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L+P: Lecture and Practice
PQ: Program Learning Outcomes
LO: Course Learning Outcomes