Department of Biomedical Engineering

BME 436 | Course Introduction and Application Information

Course Name

Medical Device Policies and Regulations

Code	Semester	Theory (hour/week)	Application/Lab (hour/week)	Local Credits	ECTS
BME 436	FALL	3	0	3	5

Prerequisites	None
Course Language	English
Course Type	ELECTIVE_COURSE
Course Level	First Cycle
Mode of Delivery	Face-To-Face
Teaching Methods and Techniques of the Course	Presentation Question/Answer
National Occupational Classification Code	-
Course Coordinator	-
Course Lecturer(s)	Dr. Öğr. Üyesi Yalın Kılıç
Assistant(s)	Dr. Öğr. Üyesi Yalın Kılıç

Course Objectives

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.

Learning Outcomes

The students who succeeded in this course;

Name	Description	PC Sub	* Contribution Level
Name	Description	PC Sub	1	2	3	4	5
LO1	will be able to define medical devices.	1.5		X
LO2	will be able to discuss the role of medical devices within healthcare policies in the world and in Turkey.	6.1		X
LO3	will be able to explain medical device labeling and the medical device classification system.	1.5		X
LO4	will be able to evaluate different technical files.	6.1			X
LO5	will be able to define priorities for innovation in medical devices.	6.1			X

Course Description

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.

Related Sustainable Development Goals

Course Category	Core Courses
	Major Area Courses	X
	Supportive Courses
	Media and Managment Skills Courses
	Transferable Skill Courses

WEEKLY SUBJECTS AND RELATED PREPARATION STUDIES

Week	Subjects	Required Materials	Learning Outcome
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		-

Course Notes/Textbooks

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

Suggested Readings/Materials

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

EVALUATION SYSTEM

Semester Activities	Number	Weighting	LO1	LO2	LO3	LO4	LO5
Project	1	50	X	X	X	X	X
Midterm	1	20	X	X	X
Final Exam	1	30	X	X	X	X	X
Total	3	100

ECTS / WORKLOAD TABLE

Semester Activities	Number	Duration (Hours)	Workload
Participation	-	-	-
Theoretical Course Hours	16	3	48
Laboratory / Application Hours	-	-	-
Study Hours Out of Class	14	2	28
Field Work	-	-	-
Quizzes / Studio Critiques	-	-	-
Portfolio	-	-	-
Homework / Assignments	-	-	-
Presentation / Jury	-	-	-
Project	1	32	32
Seminar / Workshop	-	-	-
Oral Exams	-	-	-
Midterms	1	18	18
Final Exam	1	24	24
		Total	150

COURSE LEARNING OUTCOMES AND PROGRAM QUALIFICATIONS RELATIONSHIP

#	PC Sub	Program Competencies/Outcomes	* Contribution Level
#	PC Sub	Program Competencies/Outcomes	1	2	3	4	5
1	Engineering Knowledge: Knowledge of mathematics, science, basic engineering, computation, and related engineering discipline-specific topics; the ability to apply this knowledge to solve complex engineering problems.
	1	Mathematics
	2	Science
	3	Basic Engineering
	4	Computation
	5	Related engineering discipline-specific topics		LO1 LO3
	6	The ability to apply this knowledge to solve complex engineering problems
2	Problem Analysis: Ability to identify, formulate and analyze complex engineering problems using basic knowledge of science, mathematics and engineering, and considering the UN Sustainable Development Goals relevant to the problem being addressed.
3	Engineering Design: The ability to devise creative solutions to complex engineering problems; the ability to design complex systems, processes, devices or products to meet current and future needs, considering realistic constraints and conditions.
	1	Ability to design creative solutions to complex engineering problems
	2	Ability to design complex systems, processes, devices or products to meet current and future needs, considering realistic constraints and conditions
4	Use of Techniques and Tools: Ability to select and use appropriate techniques, resources, and modern engineering and computing tools, including estimation and modeling, for the analysis and solution of complex engineering problems, while recognizing their limitations.
5	Research and Investigation: Ability to use research methods to investigate complex engineering problems, including literature research, designing and conducting experiments, collecting data, and analyzing and interpreting results.
	1	Literature research for the study of complex engineering problems
	2	Designing experiments
	3	Ability to use research methods, including conducting experiments, collecting data. analyzing and interpreting results
6	Global Impact of Engineering Practices: Knowledge of the impacts of engineering practices on society, health and safety, economy, sustainability, and the environment, within the context of the UN Sustainable Development Goals; awareness of the legal implications of engineering solutions.
	1	Knowledge of the impacts of engineering practices on society, health and safety, economy, sustainability, and the environment, within the context of the UN Sustainable Development Goals		LO2	LO4 LO5
	2	Awareness of the legal implications of engineering solutions
7	Ethical Behavior: Acting in accordance with the principles of the engineering profession, knowledge about ethical responsibility; awareness of being impartial, without discrimination, and being inclusive of diversity.
	1	Acting in accordance with the principles of the engineering profession, knowledge about ethical responsibility ethical responsibility
	2	Awareness of being impartial and inclusive of diversity, without discriminating on any subject
8	Individual and Teamwork: Ability to work effectively, individually and as a team member or leader on interdisciplinary and multidisciplinary teams (face-to-face, remote or hybrid).
	1	Ability to work individually and within the discipline
	2	Ability to work effectively as a team member or leader in multidisciplinary teams (face-to-face, remote or hybrid)
9	Verbal and Written Communication: Taking into account the various differences of the target audience (such as education, language, profession) on technical issues.
	1	Ability to communicate verbally
	2	Ability to communicate effectively in writing
10	Project Management: Knowledge of business practices such as project management and economic feasibility analysis; awareness of entrepreneurship and innovation.
	1	Knowledge of business practices such as project management and economic feasibility analysis
	2	Awareness of entrepreneurship and innovation
11	Lifelong Learning: Lifelong learning skills that include being able to learn independently and continuously, adapting to new and developing technologies, and thinking questioningly about technological changes.