Course Detail
Course Description
Course | Code | Semester | T+P (Hour) | Credit | ECTS |
---|
PRINCIPLES of MEDICAL DEVICE DESIGN | BME4110774 | Fall Semester | 3+0 | 3 | 6 |
Prerequisites Courses | |
Recommended Elective Courses | |
Language of Course | English |
Course Level | First Cycle (Bachelor's Degree) |
Course Type | Elective |
Course Coordinator | Assist.Prof. Mehmet KOCATÜRK |
Name of Lecturer(s) | Assist.Prof. Mehmet KOCATÜRK |
Assistant(s) | |
Aim | The aim of this course is to introduce the fundamentals of biomedical device design and manufacturing, and evaluate the steps toward complying with medical device regulations. |
Course Content | This course contains; Benefit-Risk Determination
,Medical Devices,Classification of Medical Devices,Medical Device Regulation (MDR),Summary of Safety and Effectiveness Data (SSED),Bioelectronics Design Perspective (Biosignal Acquisition and Filtering),Functional Electrical Stimulation,Biocompatibility Perspective (Implantable Neural Interfaces),Biocompatibility Perspective (Implantable Neural Interfaces),Artificial Intelligence for Medical Devices,Clinical Evaluation,Intellectual Property: Patents, Copyrights, Trade Secrets, and Licensing,Therapeutic Medical Devices (I),Therapeutic Medical Devices (II). |
Dersin Öğrenme Kazanımları | Teaching Methods | Assessment Methods |
Classifies the medical devices. | 10, 14, 16, 19, 2, 5, 9 | A, F |
Evaluates the medical device development, testing and marketing processes. | 10, 14, 16, 19, 2, 5, 9 | A, F |
Discusses the design requirements of the medical devices from the bioelectronic, biomaterials and biomechanics perspective. | 10, 14, 16, 17, 19, 5, 9 | A, F |
Evaluates digital signal processing methods in medical devices. | 10, 13, 14, 16, 17, 19, 21, 3, 5, 9 | A, E |
Provides solutions for analog-to-digital and digital-to-analog signal conversion issues in medical devices. | 10, 14, 16, 19, 21, 3, 5, 9 | A, E |
Teaching Methods: | 10: Discussion Method, 13: Case Study Method, 14: Self Study Method, 16: Question - Answer Technique, 17: Experimental Technique, 19: Brainstorming Technique, 2: Project Based Learning Model, 21: Simulation Technique, 3: Problem Baded Learning Model, 5: Cooperative Learning, 9: Lecture Method |
Assessment Methods: | A: Traditional Written Exam, E: Homework, F: Project Task |
Course Outline
Order | Subjects | Preliminary Work |
---|
0 | Benefit-Risk Determination
| |
1 | Medical Devices | |
2 | Classification of Medical Devices | |
3 | Medical Device Regulation (MDR) | |
4 | Summary of Safety and Effectiveness Data (SSED) | |
5 | Bioelectronics Design Perspective (Biosignal Acquisition and Filtering) | |
6 | Functional Electrical Stimulation | |
7 | Biocompatibility Perspective (Implantable Neural Interfaces) | |
8 | Biocompatibility Perspective (Implantable Neural Interfaces) | |
9 | Artificial Intelligence for Medical Devices | |
10 | Clinical Evaluation | |
11 | Intellectual Property: Patents, Copyrights, Trade Secrets, and Licensing | |
12 | Therapeutic Medical Devices (I) | |
13 | Therapeutic Medical Devices (II) | |
Resources |
1- The European Union Medical Device Regulation of 2017.
2- King PH, Fries RC, Johnson AT, Design of Biomedical Devices and Systems, 4th Edition, CRC Press: Boca Raton, 2019. 3- DeMArco, Medical Device Design and Regulation, ASQ Quality Press: Milwaukee, 2011.
|
Course Contribution to Program Qualifications
Course Contribution to Program Qualifications |
No | Program Qualification | Contribution Level |
1 | 2 | 3 | 4 | 5 |
1 | An ability to apply knowledge of mathematics, science, and engineering | | | | X | |
2 | An ability to identify, formulate, and solve engineering problems | | | | | X |
3 | An ability to design a system, component, or process to meet desired needs within realistic constraints such as economic, environmental, social, political, ethical, health and safety, manufacturability, and sustainability | | | | | X |
4 | An ability to use the techniques, skills, and modern engineering tools necessary for engineering practice | | | | | X |
5 | An ability to use the techniques, skills, and modern engineering tools necessary for engineering practice | | | | X | |
6 | An ability to function on multidisciplinary teams | | | | | X |
7 | An ability to communicate effectively | | | | | X |
8 | A recognition of the need for, and an ability to engage in life-long learning | | | | X | |
9 | An understanding of professional and ethical responsibility | | | | X | |
10 | A knowledge of contemporary issues | | | | | X |
11 | The broad education necessary to understand the impact of engineering solutions in a global, economic, environmental, and societal context | | | | | X |
12 | Capability to apply and decide on engineering principals while understanding and rehabilitating the human body | | | | | X |
Assessment Methods
Contribution Level | Absolute Evaluation |
Rate of Midterm Exam to Success | | 30 |
Rate of Final Exam to Success | | 70 |
Total | | 100 |
ECTS / Workload Table |
Activities | Number of | Duration(Hour) | Total Workload(Hour) |
Course Hours | 14 | 3 | 42 |
Guided Problem Solving | 0 | 0 | 0 |
Resolution of Homework Problems and Submission as a Report | 1 | 20 | 20 |
Term Project | 0 | 0 | 0 |
Presentation of Project / Seminar | 2 | 15 | 30 |
Quiz | 0 | 0 | 0 |
Midterm Exam | 1 | 35 | 35 |
General Exam | 1 | 45 | 45 |
Performance Task, Maintenance Plan | 0 | 0 | 0 |
Total Workload(Hour) | 172 |
Dersin AKTS Kredisi = Toplam İş Yükü (Saat)/30*=(172/30) | 6 |
ECTS of the course: 30 hours of work is counted as 1 ECTS credit. |
Detail Informations of the Course
Course Description
Course | Code | Semester | T+P (Hour) | Credit | ECTS |
---|
PRINCIPLES of MEDICAL DEVICE DESIGN | BME4110774 | Fall Semester | 3+0 | 3 | 6 |
Prerequisites Courses | |
Recommended Elective Courses | |
Language of Course | English |
Course Level | First Cycle (Bachelor's Degree) |
Course Type | Elective |
Course Coordinator | Assist.Prof. Mehmet KOCATÜRK |
Name of Lecturer(s) | Assist.Prof. Mehmet KOCATÜRK |
Assistant(s) | |
Aim | The aim of this course is to introduce the fundamentals of biomedical device design and manufacturing, and evaluate the steps toward complying with medical device regulations. |
Course Content | This course contains; Benefit-Risk Determination
,Medical Devices,Classification of Medical Devices,Medical Device Regulation (MDR),Summary of Safety and Effectiveness Data (SSED),Bioelectronics Design Perspective (Biosignal Acquisition and Filtering),Functional Electrical Stimulation,Biocompatibility Perspective (Implantable Neural Interfaces),Biocompatibility Perspective (Implantable Neural Interfaces),Artificial Intelligence for Medical Devices,Clinical Evaluation,Intellectual Property: Patents, Copyrights, Trade Secrets, and Licensing,Therapeutic Medical Devices (I),Therapeutic Medical Devices (II). |
Dersin Öğrenme Kazanımları | Teaching Methods | Assessment Methods |
Classifies the medical devices. | 10, 14, 16, 19, 2, 5, 9 | A, F |
Evaluates the medical device development, testing and marketing processes. | 10, 14, 16, 19, 2, 5, 9 | A, F |
Discusses the design requirements of the medical devices from the bioelectronic, biomaterials and biomechanics perspective. | 10, 14, 16, 17, 19, 5, 9 | A, F |
Evaluates digital signal processing methods in medical devices. | 10, 13, 14, 16, 17, 19, 21, 3, 5, 9 | A, E |
Provides solutions for analog-to-digital and digital-to-analog signal conversion issues in medical devices. | 10, 14, 16, 19, 21, 3, 5, 9 | A, E |
Teaching Methods: | 10: Discussion Method, 13: Case Study Method, 14: Self Study Method, 16: Question - Answer Technique, 17: Experimental Technique, 19: Brainstorming Technique, 2: Project Based Learning Model, 21: Simulation Technique, 3: Problem Baded Learning Model, 5: Cooperative Learning, 9: Lecture Method |
Assessment Methods: | A: Traditional Written Exam, E: Homework, F: Project Task |
Course Outline
Order | Subjects | Preliminary Work |
---|
0 | Benefit-Risk Determination
| |
1 | Medical Devices | |
2 | Classification of Medical Devices | |
3 | Medical Device Regulation (MDR) | |
4 | Summary of Safety and Effectiveness Data (SSED) | |
5 | Bioelectronics Design Perspective (Biosignal Acquisition and Filtering) | |
6 | Functional Electrical Stimulation | |
7 | Biocompatibility Perspective (Implantable Neural Interfaces) | |
8 | Biocompatibility Perspective (Implantable Neural Interfaces) | |
9 | Artificial Intelligence for Medical Devices | |
10 | Clinical Evaluation | |
11 | Intellectual Property: Patents, Copyrights, Trade Secrets, and Licensing | |
12 | Therapeutic Medical Devices (I) | |
13 | Therapeutic Medical Devices (II) | |
Resources |
1- The European Union Medical Device Regulation of 2017.
2- King PH, Fries RC, Johnson AT, Design of Biomedical Devices and Systems, 4th Edition, CRC Press: Boca Raton, 2019. 3- DeMArco, Medical Device Design and Regulation, ASQ Quality Press: Milwaukee, 2011.
|
Course Contribution to Program Qualifications
Course Contribution to Program Qualifications |
No | Program Qualification | Contribution Level |
1 | 2 | 3 | 4 | 5 |
1 | An ability to apply knowledge of mathematics, science, and engineering | | | | X | |
2 | An ability to identify, formulate, and solve engineering problems | | | | | X |
3 | An ability to design a system, component, or process to meet desired needs within realistic constraints such as economic, environmental, social, political, ethical, health and safety, manufacturability, and sustainability | | | | | X |
4 | An ability to use the techniques, skills, and modern engineering tools necessary for engineering practice | | | | | X |
5 | An ability to use the techniques, skills, and modern engineering tools necessary for engineering practice | | | | X | |
6 | An ability to function on multidisciplinary teams | | | | | X |
7 | An ability to communicate effectively | | | | | X |
8 | A recognition of the need for, and an ability to engage in life-long learning | | | | X | |
9 | An understanding of professional and ethical responsibility | | | | X | |
10 | A knowledge of contemporary issues | | | | | X |
11 | The broad education necessary to understand the impact of engineering solutions in a global, economic, environmental, and societal context | | | | | X |
12 | Capability to apply and decide on engineering principals while understanding and rehabilitating the human body | | | | | X |
Assessment Methods
Contribution Level | Absolute Evaluation |
Rate of Midterm Exam to Success | | 30 |
Rate of Final Exam to Success | | 70 |
Total | | 100 |
Numerical Data
Ekleme Tarihi: 09/10/2023 - 10:40Son Güncelleme Tarihi: 09/10/2023 - 10:41
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