Biyomedikal Mühendisliği

BME 436 | Ders Tanıtım Bilgileri

Dersin Adı

Medical Device Policies and Regulations

Kodu	Yarıyıl	Teori (saat/hafta)	Uygulama/Lab (saat/hafta)	Yerel Kredi	AKTS
BME 436	FALL	3	0	3	5

Ön-Koşul(lar)	Yok
Dersin Dili	English
Dersin Türü	ELECTIVE_COURSE
Dersin Düzeyi	Lisans
Dersin Veriliş Şekli	Face-To-Face
Dersin Öğretim Yöntem ve Teknikleri	Presentation Question/Answer
Ulusal Meslek Sınıflandırma Kodu	-
Dersin Koordinatörü	-
Öğretim Eleman(lar)ı	Dr. Öğr. Üyesi Yalın Kılıç
Yardımcı(ları)	Dr. Öğr. Üyesi Yalın Kılıç

Dersin Amacı

The aim of this course is to introduce the role of medical devices in healthcare policies and the regulations that medical device manufacturers must comply with.

Öğrenme Çıktıları

Bu dersi başarıyla tamamlayabilen öğrenciler;

Ad	Açıklama	PC Alt	* Katkı Düzeyi
Ad	Açıklama	PC Alt	1	2	3	4	5
LO1	will be able to define medical devices.			X
LO2	will be able to discuss the role of medical devices within healthcare policies in the world and in Turkey.			X
LO3	will be able to explain medical device labeling and the medical device classification system.			X
LO4	will be able to evaluate different technical files.				X
LO5	will be able to define priorities for innovation in medical devices.				X

Ders Tanımı

The course covers the World Health Organization's recommendations regarding medical devices for the world and Turkey, central government policies and decisions, the Medical Device Regulation that medical device manufacturers and importers must comply with, the Principles of the Quality Management System for Medical Devices, and similar legal regulations and directives.

Dersin İlişkili Olduğu Sürdürülebilir Kalkınma Amaçları

Dersin Kategorisi	Temel Ders
	Uzmanlık/Alan Dersleri	X
	Destek Dersleri
	İletişim ve Yönetim Becerileri Dersleri
	Aktarılabilir Beceri Dersleri

HAFTALIK KONULAR VE İLGİLİ ÖN HAZIRLIK ÇALIŞMALARI

Hafta	Konular	Ön Hazırlık	Öğrenme Çıktısı
1	Introduction	Lecture Notes	LO1
2	Definition of Medical Devices	Development of medical device policies, WHO Medical device technical series	LO1
3	Policies and Decisions Regarding Medical Devices	Definition of the Terms ‘Medical Device’ and ‘In Vitro Diagnostic (IVD) Medical Device’ , Global Harmonization Task Force	LO2
4	Legal Regulations on the Quality and Safety of Medical Devices	Regulation of medical devices: A step-by-step guide, WHO Regional Publications, Eastern Mediterranean Series	LO3
5	Medical Device Regulations and the Medical Device Directive	Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC. Official Journal of the European Union	LO2
6	In Vitro Diagnostic Device Regulation	Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU. Official Journal of the European Union	LO2
7	Quality Management System for Medical Device Manufacturing	Edward P Link. An Audit of the System, not of the People - An ISO 13485:2016 Pocket Guide for Every Employee	LO3
8	Midterm		-
9	Standards in User and Patient Manuals	EU MDR, Chapter III, 23.1	LO4
10	Technical File for CE Marking	International Guidelines	LO4
11	Health Technology Assessment and Management	2015 Global Survey on Health Technology Assessment by National Authorities. Main findings. I. World Health Organization.	LO4
12	Priority Medical Devices	Medical devices: Managing the Mismatch An outcome of the Priority Medical Devices project . World Health Organization	LO5
13	Target Product Profiles for Innovations in Medical Devices	A Multiplex Multi-Analyte Diagnostic Platform, Medecins Sans Frontieres	LO5
14	Medical Devices Global Atlas and Turkey's Policies	Global Atlas of medical devices, WHO medical devices technical series	LO5
15	Review of the semester		-
16	Final Exam		-

Ders Kitabı

European Medical Device Regulation (MDR) for MedTech and Medical Device Manufacturers Mr Des O'Brien ISBN: 978-1092813518

Önerilen Okumalar/Materyaller

Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices
amending Directive 2001/83/EC. Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC. Official Journal of the European Union
Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU. Official Journal of the European Union
Edward P Link . An Audit of the System not of the People - An ISO 13485:2016 Pocket Guide for Every Employee Kindle Edition Quality Pursuit Inc. (20 Aug. 2017) ASIN: B074ZLSF6S
Development of medical device policies WHO Medical device technical series

DEĞERLENDİRME ÖLÇÜTLERİ

Yarıyıl Aktiviteleri	Sayı	Katkı Payı %	LO1	LO2	LO3	LO4	LO5
Proje	1	50	X	X	X	X	X
Ara Sınav	1	20	X	X	X
Final Sınavı	1	30	X	X	X	X	X
Toplam	3	100

AKTS / İŞ YÜKÜ TABLOSU

Yarıyıl Aktiviteleri	Sayı	Süre (Saat)	İş Yükü
Katılım	-	-	-
Teorik Ders Saati	16	3	48
Laboratuvar / Uygulama Ders Saati	-	-	-
Sınıf Dışı Ders Çalışması	14	2	28
Arazi Çalışması	-	-	-
Küçük Sınav / Stüdyo Kritiği	-	-	-
Portfolyo	-	-	-
Ödev	-	-	-
Sunum / Jüri Önünde Sunum	-	-	-
Proje	1	32	32
Seminer/Çalıştay	-	-	-
Sözlü Sınav	-	-	-
Ara Sınavlar	1	18	18
Final Sınavı	1	24	24
		Toplam	150