TYPE OF COURSE UNIT	Elective Course
LEVEL OF COURSE UNIT	Master's Degree Without Thesis
YEAR OF STUDY	-
SEMESTER	-
NUMBER OF ECTS CREDITS ALLOCATED	10
NAME OF LECTURER(S)	Assistant Professor Onur Koçak
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 DELIVERY	Face to face
PRE-REQUISITES OF THE COURSE	No
RECOMMENDED OPTIONAL PROGRAMME COMPONENT	No
COURSE DEFINITION	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
RECOMENDED 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 WORKLOAD	Activities Number Hours Workload 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 Workload 299 Total Workload / 30 9,96 ECTS Credits of the Course 10
LANGUAGE OF INSTRUCTION	Turkish
WORK PLACEMENT(S)	No