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COURSE UNIT TITLECOURSE UNIT CODESEMESTERTHEORY + PRACTICE (Hour)ECTS
MEDICAL PRODUCT DESIGN AND DEVELOPMENT BME529 ------- 3 + 0 10

TYPE OF COURSE UNITElective Course
LEVEL OF COURSE UNITMaster's Degree Without Thesis
YEAR OF STUDY-
SEMESTER-------
NUMBER OF ECTS CREDITS ALLOCATED10
NAME OF LECTURER(S)-
LEARNING OUTCOMES OF THE COURSE UNIT At the end of this course, the students;
1) to learn about types of medical devices
2) to learn medical device criteria
3) to learn about regulatory issues, agencies
4) to gain knowledge about related standarts
5) to learn about funding agencies
MODE OF DELIVERYFace to face
PRE-REQUISITES OF THE COURSENo
RECOMMENDED OPTIONAL PROGRAMME COMPONENTNo
COURSE DEFINITIONBiomedical 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
WEEKTOPICS
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
RECOMENDED OR REQUIRED READINGBiodesign: The Process of Innovating Medical Technologies, Stefanos Zenios, Josh Makower, Paul Yock, Cambridge University Press
PLANNED LEARNING ACTIVITIES AND TEACHING METHODSLecture,Presentation,Project
ASSESSMENT METHODS AND CRITERIA
 QuantityPercentage(%)
Mid-term135
Project130
Total(%)65
Contribution of In-term Studies to Overall Grade(%)65
Contribution of Final Examination to Overall Grade(%)35
Total(%)100
ECTS WORKLOAD
Activities Number Hours Workload
Midterm exam17272
Preparation for Quiz000
Individual or group work236
Preparation for Final exam12424
Course hours14342
Preparation for Midterm exam11111
Laboratory (including preparation)000
Final exam19696
Homework
Project14848
Total Workload299
Total Workload / 309,96
ECTS Credits of the Course10
LANGUAGE OF INSTRUCTIONEnglish
WORK PLACEMENT(S)No
  

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