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FIRST CYCLE - BACHELOR'S DEGREE
FACULTY OF TECHNOLOGY
BIOMEDICAL ENGINEERING DEPARTMENT
185 BIOMEDICAL ENGINEERING
Course Information
Course Learning Outcomes
Course's Contribution To Program
ECTS Workload
Course Details
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COURSE INFORMATION
Course Code
Course Title
L+P Hour
Semester
ECTS
BMM 331
ESTABLISHING A QUALITY MANAGEMENT SYSTEM IN MEDICAL DEVICES
2 + 0
5th Semester
2
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
1
Awareness in quality management systems
2
Ability to prepare a document
3
Knowledge in calibration
4
Preparing a calibration document
COURSE'S CONTRIBUTION TO PROGRAM
PO 01
PO 02
PO 03
PO 04
PO 05
PO 06
PO 07
PO 08
PO 09
PO 10
PO 11
PO 12
PO 13
PO 14
LO 001
LO 002
LO 003
LO 004
Sub Total
Contribution
0
0
0
0
0
0
0
0
0
0
0
0
0
0
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
2
28
Mid-terms
1
10
10
Final examination
1
14
14
Total Work Load
ECTS Credit of the Course
52
2
COURSE DETAILS
Select Year
All Years
2023-2024 Fall
2022-2023 Fall
Course Term
No
Instructors
Details
2023-2024 Fall
1
AHMET KOLUMAN
Print
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
Weeks
Topics
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 Methods
Percentage (%)
Assesment Methods Title
Final Exam
60
Final Exam
Midterm Exam
40
Midterm Exam
L+P:
Lecture and Practice
PQ:
Program Learning Outcomes
LO:
Course Learning Outcomes
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Home Page
About University
Name And Address
Acedemic Authorities
General Discription
Academic Calendar
General Admission Requirements
Recognition of Prior Learning
General Registration Procedures
ECTS Credit Allocation
Academic Guidance
Information For Students
Cost Of Living
Accommodation
Meals
Medical Facilities
Facilities for Special Needs Students
Insurance
Financial Support for Students
Student Affairs
Learning Facilities
International Programs
Language Courses
Internships
Sports Facilities and Leisure Activities
Student Associations
Practical Information for Mobile Students
Degree Programmes