FACULTY OF ENGINEERING
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/Spring
|
3
|
0
|
3
|
5
|
Prerequisites |
None
|
|||||
Course Language |
English
|
|||||
Course Type |
Elective
|
|||||
Course Level |
First Cycle
|
|||||
Mode of Delivery | - | |||||
Teaching Methods and Techniques of the Course | - | |||||
Course Coordinator | ||||||
Course Lecturer(s) | ||||||
Assistant(s) | - |
Course Objectives | The aim of this course is to give an introduction to policies for medical devices in health plan and mandatory regulations for medical device manufacturers. |
Learning Outcomes |
The students who succeeded in this course;
|
Course Description | The course covers recommendations of World Health Organization, framework policies and resolutions and regulations about medical devices in Turkey and globally; also the principles of Medical Device Directive, quality management system for medical devices and similar legal regulations and directives for medical device manufacturers and importers. |
|
Core Courses | |
Major Area Courses |
X
|
|
Supportive Courses | ||
Media and Management Skills Courses | ||
Transferable Skill Courses |
WEEKLY SUBJECTS AND RELATED PREPARATION STUDIES
Week | Subjects | Related Preparation |
1 | Introduction to BME 4xx Lecture | |
2 | Definition of Medical Devices | Development of medical device policies, WHO Medical device technical series |
3 | Policies and Resolutions on Medical Devices | Definition of the Terms ‘Medical Device’ and ‘In Vitro Diagnostic (IVD) Medical Device’ , Global Harmonization Task Force |
4 | Quality and Safety Regulations for Medical Devices | Regulation of medical devices: A step-by-step guide, WHO Regional Publications, Eastern Mediterranean Series |
5 | Medical Device Directives and Medical Device Regulations | 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 |
6 | In Vitro Diagnostic Device Regulations | 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 |
7 | Quality Management System for Manufacturing Medical Devices | Edward P Link. An Audit of the System, not of the People - An ISO 13485:2016 Pocket Guide for Every Employee |
8 | Technical Dossier for CE Marking | Guidance Technical Documentation and Design Dossiers for Non Active Medical Devices, TÜV Süd Product Service GmbH |
9 | Standards in Instructions for Use and Patient Manuals | EU MDR, Chapter III, 23.1 |
10 | Review and Mid-term Exam | |
11 | Health Technology Assessment and Management | 2015 Global Survey on Health Technology Assessment by National Authorities. Main findings. I. World Health Organization. |
12 | Priority Medical Devices | Medical devices: Managing the Mismatch An outcome of the Priority Medical Devices project . World Health Organization |
13 | Target Product Profiles in Medical Device Innovation | A Multiplex Multi-Analyte Diagnostic Platform, Medecins Sans Frontieres |
14 | Global Atlas of Medical Devices and Policies of Turkey | Global Atlas of medical devices, WHO medical devices technical series |
15 | Review | |
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 |
EVALUATION SYSTEM
Semester Activities | Number | Weigthing |
Participation | ||
Laboratory / Application | ||
Field Work | ||
Quizzes / Studio Critiques | ||
Portfolio | ||
Homework / Assignments | ||
Presentation / Jury | ||
Project |
1
|
50
|
Seminar / Workshop | ||
Oral Exams | ||
Midterm |
1
|
20
|
Final Exam |
1
|
30
|
Total |
Weighting of Semester Activities on the Final Grade |
2
|
70
|
Weighting of End-of-Semester Activities on the Final Grade |
1
|
30
|
Total |
ECTS / WORKLOAD TABLE
Semester Activities | Number | Duration (Hours) | Workload |
---|---|---|---|
Theoretical Course Hours (Including exam week: 16 x total hours) |
16
|
3
|
48
|
Laboratory / Application Hours (Including exam week: '.16.' x total hours) |
16
|
0
|
|
Study Hours Out of Class |
0
|
||
Field Work |
0
|
||
Quizzes / Studio Critiques |
0
|
||
Portfolio |
0
|
||
Homework / Assignments |
0
|
||
Presentation / Jury |
0
|
||
Project |
1
|
60
|
60
|
Seminar / Workshop |
0
|
||
Oral Exam |
0
|
||
Midterms |
1
|
18
|
18
|
Final Exam |
1
|
22
|
22
|
Total |
148
|
COURSE LEARNING OUTCOMES AND PROGRAM QUALIFICATIONS RELATIONSHIP
#
|
Program Competencies/Outcomes |
* Contribution Level
|
||||
1
|
2
|
3
|
4
|
5
|
||
1 | To have adequate knowledge in Mathematics, Science and Biomedical Engineering; to be able to use theoretical and applied information in these areas on complex engineering problems. |
|||||
2 | To be able to identify, define, formulate, and solve complex Biomedical Engineering problems; to be able to select and apply proper analysis and modeling methods for this purpose. |
|||||
3 | To be able to design a complex system, process, device or product under realistic constraints and conditions, in such a way as to meet the requirements; to be able to apply modern design methods for this purpose. |
X | ||||
4 | To be able to devise, select, and use modern techniques and tools needed for analysis and solution of complex problems in Biomedical Engineering applications. |
|||||
5 | To be able to design and conduct experiments, gather data, analyze and interpret results for investigating complex engineering problems or Biomedical Engineering research topics. |
X | ||||
6 | To be able to work efficiently in Biomedical Engineering disciplinary and multi-disciplinary teams; to be able to work individually. |
X | ||||
7 | To be able to communicate effectively in Turkish, both orally and in writing; to be able to author and comprehend written reports, to be able to prepare design and implementation reports, to present effectively, to be able to give and receive clear and comprehensible instructions. |
|||||
8 | To have knowledge about global and social impact of Biomedical Engineering practices on health, environment, and safety; to have knowledge about contemporary issues as they pertain to engineering; to be aware of the legal ramifications of engineering solutions. |
X | ||||
9 | To be aware of ethical behavior, professional and ethical responsibility; to have knowledge about standards utilized in engineering applications. |
|||||
10 | To have knowledge about industrial practices such as project management, risk management, and change management; to have awareness of entrepreneurship and innovation; to have knowledge about sustainable development. |
X | ||||
11 | To be able to collect data in the area of Biomedical Engineering, and to be able to communicate with colleagues in a foreign language. |
|||||
12 | To be able to speak a second foreign language at a medium level of fluency efficiently. |
|||||
13 | To recognize the need for lifelong learning; to be able to access information, to be able to stay current with developments in science and technology; to be able to relate the knowledge accumulated throughout the human history to Biomedical Engineering. |
X |
*1 Lowest, 2 Low, 3 Average, 4 High, 5 Highest
NEWS |ALL NEWS
Biomedical Engineering Erasmus Agreement was signed with Universidad Jaume University, Spain
The signing process for the agreement with Universidad Jaume for Biomedical Engineering has been completed. Our students can add this university to
OCCUPATIONAL HEALTH AND SAFETY TRAINING
Within the scope of BME 318 course, an Occupational Health and Safety Seminar was given to Biomedical Engineering students by our University's
An Oligonucleotide Story by Assoc. Prof. Dr. Osman DOLUCA
Within the scope of the Biomedical symposium organized by İzmir Katip Çelebi University Biomedical Society, our department chair, Assoc. Prof. Dr. Osman
Projects were entitled to receive support within the scope of the TÜBİTAK 2209-A
We congratulate our students and wish them continued success.
Important breakthrough in virus detection
Assoc. Prof. Dr. Osman Doluca, Acting Head of Department of Biomedical Engineering, Izmir University of Economics (IUE), reported that they have developed
'Smart cabinet' against the virus
Assoc. Prof. Dr. Osman Doluca and his 4 students from Izmir University of Economics (IUE) developed a 'PCR cabinet' that allows samples