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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) |
|
|||||
| Assistant(s) |
|
|||||
| 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;
|
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| 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 |
-
|
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|
|
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 | ||||
| 1 | 2 | 3 | 4 | 5 | |||
| No program competency data found. | |||||||
*1 Lowest, 2 Low, 3 Average, 4 High, 5 Highest
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