COURSE INTRODUCTION AND APPLICATION INFORMATION


Course Name
Fundamentals of Medical Devices and Products
Code
Semester
Theory
(hour/week)
Application/Lab
(hour/week)
Local Credits
ECTS
BME 368
Fall/Spring
2
2
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 objective of this course is to introduce the medical products and development of medical products .This course will cover classification of medical products, design of medical products and the regulations on medical products
Learning Outcomes The students who succeeded in this course;
  • will be able to explain medical products
  • will be able to define use of medical products and devices
  • will be able to evaluate classification of medical products
  • will be able to discuss the regulations on medical products
  • will be able to describe the design of medical products
  • will be able to analyze the safety of biomedical products
Course Description The course covers medical products, development of medical products and medical devices and regulations of such products
Related Sustainable Development Goals

 



Course Category

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
1 Introduction to BME 210 Lecture
2 Definition of Medical Devices Elaine Whitmore, 2012. “Development of FDA-Regulated Medical Products”. Second Edition, Quality press, Milwaukee-Part I
3 Policies and Resolutions on Medical Devices Elaine Whitmore, 2012. “Development of FDA-Regulated Medical Products”. Second Edition, Quality press, Milwaukee-Part I
4 Quality and Safety Regulations for Medical Devices Peter Ogrodnik 2013. “ Medical Device Design Innovation from Concept to Market”, Elsevier Ltd., Oxford Chapter 2
5 Quality and Safety Regulations for Medical Devices Elaine Whitmore, 2012. “Development of FDA-Regulated Medical Products”. Second Edition, Quality press, Milwaukee-Part I Chapter 5
6 Medical Device Directives and Medical Device Regulations Elaine Whitmore, 2012. “Development of FDA-Regulated Medical Products”. Second Edition, Quality press, Milwaukee-Part II
7 Quality Management System for Manufacturing Medical Devices Elaine Whitmore, 2012. “Development of FDA-Regulated Medical Products”. Second Edition, Quality press, Milwaukee-Part II
8 Technical Dossier for CE Marking Peter Ogrodnik 2013. “ Medical Device Design Innovation from Concept to Market”, Elsevier Ltd., Oxford Chapter 3
9 Standards in Instructions for Use and Patient Manuals Peter Ogrodnik 2013. “ Medical Device Design Innovation from Concept to Market”, Elsevier Ltd., Oxford Chapter 7
10 Review Elaine Whitmore, 2012. “Development of FDA-Regulated Medical Products”. Second Edition, Quality press, Milwaukee-Part I
11 Health Technology Assessment and Management Elaine Whitmore, 2012. “Development of FDA-Regulated Medical Products”. Second Edition, Quality press, Milwaukee-Part II Chapter 6
12 Priority Medical Devices Elaine Whitmore, 2012. “Development of FDA-Regulated Medical Products”. Second Edition, Quality press, Milwaukee-Part III
13 Target Product Profiles in Medical Device Innovation Elaine Whitmore, 2012. “Development of FDA-Regulated Medical Products”. Second Edition, Quality press, Milwaukee-Part II
14 Global Atlas of Medical Devices and Policies of Turkey Elaine Whitmore, 2012. “Development of FDA-Regulated Medical Products”. Second Edition, Quality press, Milwaukee-Part III
15 Review
16 Final Exam
Course Notes/Textbooks

Elaine Whitmore, 2012. “Development of FDA-Regulated Medical Products”. Second Edition, Quality press, Milwaukee

Peter Ogrodnik 2013. “ Medical Device Design Innovation from Concept to Market”, Elsevier Ltd., Oxford

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 Exam
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
Course Hours
(Including exam week: 16 x total hours)
16
2
32
Laboratory / Application Hours
(Including exam week: 16 x total hours)
16
2
Study Hours Out of Class
16
1
16
Field Work
Quizzes / Studio Critiques
Portfolio
Homework / Assignments
Presentation / Jury
Project
1
25
Seminar / Workshop
Oral Exam
Midterms
1
Final Exams
1
20
    Total
125

 

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.

X
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 Biomedical Engineering applications.

X
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.

9

To be aware of ethical behavior, professional and ethical responsibility; to have knowledge about standards utilized in engineering applications.

X
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.

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.

X
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.

*1 Lowest, 2 Low, 3 Average, 4 High, 5 Highest