| Course Type | Elective Course |
|---|
| Course Level | Master's Degree With Thesis |
|---|
| Year of Study | - |
|---|
| Semester | - |
|---|
| ECTS | 10 |
|---|
| Name of Lecturer(s) |
- |
| Learning Outcomes |
At the end of this course, the students;
- to learn about types of medical devices
- to learn medical device criteria
- to learn about regulatory issues, agencies
- to gain knowledge about related standarts
- to learn about funding agencies
|
| Mode of Delivery | Face to face |
|---|
| Prerequisites | No |
|---|
| Recommended Optional Programme Components | No |
|---|
| Course Description | Biomedical Device Design course provides information about a diverse set of disciplines to achieve a safe and successful product. This course will expose the student to several of these disciplines with the objective of raising the awareness of safety throughout the product development life cycle. Classes will be presented on the objectives of the regulatory process and some of its mechanisms, on (safety) risk management and design controls, on the use of human factors and standards, and on the design of clinical studies . |
|---|
| Course Contents |
| WEEK |
TOPICS |
|
1st Week |
Introduction to biomedical device design |
|
2nd Week |
Types of biomedical devices |
|
3rd Week |
Intracorporeal devices |
|
4th Week |
Extracorporeal devices |
|
5th Week |
Implant devices |
|
6th Week |
International standarts for medical devices |
|
7th Week |
CE marking for medical devices |
|
8th Week |
Clinical study design |
|
9th Week |
Technopolice and technoparks |
|
10th Week |
Funding agencies and programs |
|
11th Week |
Regulatory issues for medical devices |
|
12th Week |
FDA, local and international regulations |
|
13th Week |
Ethical and legal issues |
|
14th Week |
Project presentations |
|
| Recommended or Required Reading | Biodesign: The Process of Innovating Medical Technologies, Stefanos Zenios, Josh Makower, Paul Yock, Cambridge University Press |
|---|
| Planned Learning Activities and Teaching Methods |
- Lecture
- Presentation
- Project
|
|---|
| Assessment Methods and Criteria |
|
Quantity |
Percentage (%) |
| Mid-term |
1 |
35 |
| Project |
1 |
30 |
| Total(%) |
|
65 |
| Contribution of In-term Studies to Overall Grade(%) |
|
65 |
| Contribution of Final Examination to Overall Grade(%) |
|
35 |
| Total(%) |
|
100 |
|
| ECTS Allocated Based on Student Workload |
| Activities |
Quantity |
Duration (Hour) |
Total Workload (Hour) |
| Midterm exam |
1 |
72 |
72 |
| Preparation for Quiz |
0 |
0 |
0 |
| Individual or group work |
2 |
3 |
6 |
| Preparation for Final exam |
1 |
24 |
24 |
| Course hours |
14 |
3 |
42 |
| Preparation for Midterm exam |
1 |
11 |
11 |
| Laboratory (including preparation) |
0 |
0 |
0 |
| Final exam |
1 |
96 |
96 |
| Homework |
|
|
|
| Project |
1 |
48 |
48 |
| Total Work Load | 299 |
| Total Work Load / 30 (h) | 9.96 |
| ECTS Credit of the Course | 10 |
|
| Language of Instruction | Turkish |
|---|
| Work Placement(s) | No |
|---|
