PAÜ .:. Eğitim Öğretim Bilgi Sistemi

COURSE INFORMATION

Course Code	Course Title	L+P Hour	Semester	ECTS
BMM 223	MEDICAL DEVICE REGULATIONS AND PROCESSES	2 + 0	8th Semester	3

COURSE DESCRIPTION

Course Level	Bachelor's Degree
Course Type	Compulsory
Course Objective	The aim of this course is to learn the legal regulations and processes of medical devices and accessories related to the quality, standard, purpose of use, placing on the market, keeping them on the market, use in clinical research and putting them into service for patients, users and other persons.
Course Content	Placing the Devices on the Market and Putting them into Service, Obligations of Economic Operators, Reprocessing, CE Marking, Free Movement, European Database on Medical Devices, National Product Tracking System, Notified Bodies, Classification and Conformity Assessment, Clinical Evaluation and Clinical Trials, Post-Market Surveillance, Vigilance and Market Surveillance and Inspection, Cross-Country Cooperation, Medical Device Coordination Group and Device Logs
Prerequisites	No the prerequisite of lesson.
Corequisite	No the corequisite of lesson.
Mode of Delivery	Face to Face

COURSE LEARNING OUTCOMES

1	To learn the medical device regulation of the Ministry of Health
2	To know national and international medical device standards.
3	To learn the procedures and principles for placing medical devices on the market.
4	To learn the standards for the use of medical devices for clinical research.

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	2	28
Mid-terms	1	20	20
Final examination	1	22	22
Internet Searching/ Library Study	1	8	8
Total Work Load ECTS Credit of the Course			78 3

COURSE DETAILS

Select Year

	Course Term	No	Instructors
Details	2023-2024 Fall	1	ÇİĞDEM ÇİMENOĞLU

Course Details

Course Code	Course Title	L+P Hour	Course Code	Language Of Instruction	Course Semester
BMM 223	MEDICAL DEVICE REGULATIONS AND PROCESSES	2 + 0	1	Turkish	2023-2024 Fall

Course Coordinator	E-Mail	Phone Number	Course Location	Attendance
Asts. Prof. Dr. ÇİĞDEM ÇİMENOĞLU	ccimenoglu@pau.edu.tr		TEK A0008	%70

Goals		The aim of this course is to learn the legal regulations and processes of medical devices and accessories related to the quality, standard, purpose of use, placing on the market, keeping them on the market, use in clinical research and putting them into service for patients, users and other persons.
Content		Placing the Devices on the Market and Putting them into Service, Obligations of Economic Operators, Reprocessing, CE Marking, Free Movement, European Database on Medical Devices, National Product Tracking System, Notified Bodies, Classification and Conformity Assessment, Clinical Evaluation and Clinical Trials, Post-Market Surveillance, Vigilance and Market Surveillance and Inspection, Cross-Country Cooperation, Medical Device Coordination Group and Device Logs

Topics

Weeks	Topics
1	Introduction to Medical Devices
2	Medical Device Industry in Türkiye and in the World
3	Medical Device Regulations-1
4	Medical Device Regulations-2
5	Medical Device Production and Certification
6	Quality and Safety of Medical Device Production
7	Recap
8	Midterm Exam
9	Medical Device Product Tracking System and Post-Market Surveillance
10	Vigilance and Clinical Research in Medical Devices
11	Student Projects
12	Student Projects
13	Student Projects
14	Recap

Materials

Materials are not specified.

Resources

Resources	Resources Language
Tıbbi Cihaz Yönetmeliği (2/6/2021 tarihli ve 31499mükerrer sayılı RG)	Türkçe
İn vitro Tanı Amaçlı Tıbbi Cihaz Yönetmeliği (2/6/2021tarihli ve 31499 mükerrer sayılı RG)	Türkçe
Vücut Dışında Kullanılan (İn Vitro)Tıbbi TanıCihazları Yönetmeliği (09.01.2007 tarihli ve 26398 sayılı RG)	Türkçe
Hayvan Kaynaklı Dokular Kullanılarak İmal Edilen TıbbiCihazlara Dair Yönetmelik (14.01.2021 tarihli ve 31364 sayılı RG)	Türkçe
Tıbbi Cihaz Klinik Araştırmalar Yönetmeliği TR / EN	Türkçe

Course Assessment

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

Prospective Student