FACULTY OF ENGINEERING
Department of Genetics and Bioengineering
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 | ||
| 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 Genetics and Bioengineering; 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 Genetics and Bioengineering 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. |
|||||
| 4 | To be able to devise, select, and use modern techniques and tools needed for analysis and solution of complex problems in Genetics and Bioengineering applications; to be able to use information technologies effectively. |
|||||
| 5 | To be able to design and conduct experiments, gather data, analyze and interpret results for investigating complex engineering problems or Genetics and Bioengineering research topics. |
|||||
| 6 | To be able to work efficiently in Genetics and Bioengineering disciplinary and multi-disciplinary teams; to be able to work individually. |
|||||
| 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 Genetics and Bioengineering 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 Genetics and Bioengineering solutions. |
|||||
| 9 | To be aware of ethical behavior, professional and ethical responsibility; to have knowledge about standards utilized in Genetics and Bioengineering 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. |
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| 11 | To be able to collect data in the area of Genetics and Bioengineering, 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 Genetics and Bioengineering. |
|||||
*1 Lowest, 2 Low, 3 Average, 4 High, 5 Highest
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