1. FIRST CYCLE - BACHELOR'S DEGREE
  2. FACULTY OF TECHNOLOGY
  3. BIOMEDICAL ENGINEERING DEPARTMENT
  4. 185 BIOMEDICAL ENGINEERING
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
BMM 331ESTABLISHING A QUALITY MANAGEMENT SYSTEM IN MEDICAL DEVICES2 + 05th Semester2

COURSE DESCRIPTION
Course Level Bachelor's Degree
Course Type Compulsory
Course Objective In this lecture ISO 13485 Medical device quality assurance standard will be examined throughly.
Course Content In this lecture General Quality management Applications ISO 22000 ISO 9001 ISO 13485 ISO 17025 ISO 17043 Calibration, and document preparation will be told.
Prerequisites No the prerequisite of lesson.
Corequisite No the corequisite of lesson.
Mode of Delivery Face to Face

COURSE LEARNING OUTCOMES
1Awareness in quality management systems
2Ability to prepare a document
3Knowledge in calibration
4Preparing a calibration document

COURSE'S CONTRIBUTION TO PROGRAM
PO 01PO 02PO 03PO 04PO 05PO 06PO 07PO 08PO 09PO 10PO 11PO 12PO 13PO 14
LO 001              
LO 002              
LO 003              
LO 004              
Sub Total              
Contribution00000000000000

ECTS ALLOCATED BASED ON STUDENT WORKLOAD BY THE COURSE DESCRIPTION
ActivitiesQuantityDuration (Hour)Total Work Load (Hour)
Course Duration (14 weeks/theoric+practical)14228
Mid-terms11010
Final examination11414
Total Work Load

ECTS Credit of the Course





52

2
COURSE DETAILS
 Select Year   


 Course TermNoInstructors
Details 2023-2024 Fall1AHMET KOLUMAN


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Course Details
Course Code Course Title L+P Hour Course Code Language Of Instruction Course Semester
BMM 331 ESTABLISHING A QUALITY MANAGEMENT SYSTEM IN MEDICAL DEVICES 2 + 0 1 Turkish 2023-2024 Fall
Course Coordinator  E-Mail  Phone Number  Course Location Attendance
Prof. Dr. AHMET KOLUMAN akoluman@pau.edu.tr TEK A0401-03 %70
Goals In this lecture ISO 13485 Medical device quality assurance standard will be examined throughly.
Content In this lecture General Quality management Applications ISO 22000 ISO 9001 ISO 13485 ISO 17025 ISO 17043 Calibration, and document preparation will be told.
Topics
WeeksTopics
1 ISO 9001
2 ISO 9001
3 ISO 9001
4 ISO 17025
5 ISO 17025
6 ISO 17043
7 ISO 17043
8 ISO 13485
9 ISO 13485
10 ISO 13485
11 ISO 15189
12 ISO 15189
13 Harmonization with EU regulations
14 Harmonization with EU regulations
Materials
Materials are not specified.
Resources
Course Assessment
Assesment MethodsPercentage (%)Assesment Methods Title
Final Exam60Final Exam
Midterm Exam40Midterm Exam
L+P: Lecture and Practice
PQ: Program Learning Outcomes
LO: Course Learning Outcomes