PRODUCTION AND MEDICAL DEVICE LEGAL REGULATIONS IN BIOMEDICAL ENGINEERING

BME486

Course Type

Elective Course

Course Level

Bachelor's Degree

Year of Study

Semester

ECTS

Name of Lecturer(s)

Learning Outcomes

At the end of this course, the students;

Knows the concept of medical device.
Gains knowledge of the infrastructure requirements related to medical device manufacturing processes.
Gains technical knowledge about the necessary infrastructure for the production processes of different groups of medical devices.
Gains knowledge about medical device production & quality certification processes.
Knows the critical steps of MDR Certification processes (Current Regulations and regulations)
Gains knowledge about PMS.
Knows clinical research requirements.
Learn to do market analysis for medical devices
Have information about technical file preparation and documentation processes.
Gains knowledge about the creation of Risk Management.
Gains knowledge about interdisciplinary team management processes.
Gains knowledge of the reimbursement system.

Mode of Delivery

Face to face

Prerequisites

Recommended Optional Programme Components

None

Course Description

In Construction

Course Contents

WEEK	TOPICS
1^st Week	Medical device definition
2^nd Week	Distribution of medical devices in the current market
3^rd Week	Medical device manufacturing infrastructure-1
4^th Week	Medical device manufacturing infrastructure-2
5^th Week	Medical device quality management system
6^th Week	Medical device legislation-1
7^th Week	Medical device legislation-2
8^th Week	Midterm
9^th Week	Pre-market processes
10^th Week	Clinical research and risk management
11^th Week	Post-market processes
12^th Week	Medical Device National and EU Registration Processes
13^th Week	PMS Processes
14^th Week	Independent Auditing Bodies

Recommended or Required Reading

2017/745 EU Medical Device Regulation
2017/746 EU In Vitro Diagnostic Medical Device Regulation

Planned Learning Activities and Teaching Methods

Assessment Methods and Criteria

	Quantity	Percentage (%)
Mid-term	1	35
Assignment	1	25
Total(%)		60
Contribution of In-term Studies to Overall Grade(%)		60
Contribution of Final Examination to Overall Grade(%)		40
Total(%)		100

ECTS Allocated Based on Student Workload

Activities	Quantity	Duration (Hour)	Total Workload (Hour)
Midterm exam	1	2	2
Preparation for Quiz	1	15	15
Individual or group work	12	4	48
Preparation for Final exam	1	10	10
Course hours	1	2	2
Preparation for Midterm exam	3	20	60
Laboratory (including preparation)
Final exam
Homework
Total Work Load			137
Total Work Load / 30 (h)			4.56
ECTS Credit of the Course			5

Language of Instruction

Turkish

Work Placement(s)