PAÜ .:. Eğitim Öğretim Bilgi Sistemi

COURSE INFORMATION

Course Code	Course Title	L+P Hour	Semester	ECTS
BMM 680	MEDICAL DEVICE DESIGN AND MANUFACTURING	3 + 0	1st Semester	7,5

COURSE DESCRIPTION

Course Level	Doctorate Degree
Course Type	Compulsory
Course Objective	The aim of this course is to learn the regulations, standards and engineering processes in medical device design and production.
Course Content	Medical Device Definition, Classification of Medical Devices, Design and Development according to Quality Management System in Medical Devices, Medical Device Regulations in the World, Risk Management in Medical Devices, Biocompatibility, Usability Analysis, Clean Rooms and Sterilization, Biocontamination Control, Evaluation and Interpretation of Data, Software, Clinical Research, After Sales Surveillance and Clinical Tracking, Alert System, Registration Systems, EU Representation, Certification and Market Placement of Medical Devices
Prerequisites	No the prerequisite of lesson.
Corequisite	No the corequisite of lesson.
Mode of Delivery	Face to Face

COURSE LEARNING OUTCOMES

1	To be able to define and classify medical devices
2	To learn ISO standards in medical device design
3	To learn important stages such as risk management, biocompatibility, usability analysis in medical device production
4	To learn national and international regulation in medical device design and production

COURSE'S CONTRIBUTION TO PROGRAM

Data not found.

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

Select Year

Course Details

Course Code	Course Title	L+P Hour	Course Code	Language Of Instruction	Course Semester
BMM 680	MEDICAL DEVICE DESIGN AND MANUFACTURING	3 + 0	1	Turkish	2023-2024 Fall

Course Coordinator	E-Mail	Phone Number	Course Location	Attendance
Asts. Prof. Dr. EŞREF BOĞAR	ebogar@pau.edu.tr		TEK A0213 TEK A0214 TEK A0215 TEK A0216 TEK A0217 TEK A0218 TEK A0219 TEK A0302 TEK A0319 TEK A0402-22	%

Goals		The aim of this course is to learn the regulations, standards and engineering processes in medical device design and production.
Content		Medical Device Definition, Classification of Medical Devices, Design and Development according to Quality Management System in Medical Devices, Medical Device Regulations in the World, Risk Management in Medical Devices, Biocompatibility, Usability Analysis, Clean Rooms and Sterilization, Biocontamination Control, Evaluation and Interpretation of Data, Software, Clinical Research, After Sales Surveillance and Clinical Tracking, Alert System, Registration Systems, EU Representation, Certification and Market Placement of Medical Devices

Topics

Materials

Materials are not specified.

Resources

Course Assessment

Assesment Methods	Percentage (%)	Assesment Methods Title
Final Exam	50	Final Exam
Midterm Exam	50	Midterm Exam

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

Prospective Student