COURSE UNIT TITLE

: THE REGULATIONS AND PROCEURES FOR MEDICAL DEVICES

DEGREE PROGRAMMES

Description of Individual Course Units

Course Unit Code Course Unit Title Type Of Course D U L ECTS
SHS 2048 THE REGULATIONS AND PROCEURES FOR MEDICAL DEVICES ELECTIVE 2 0 0 2

Offered By

Vocational School of Healthcare

Level of Course Unit

Short Cycle Programmes (Associate's Degree)

Course Coordinator

PROFESSOR DOCTOR MEHMET ATEŞ

Offered to

Oral and Dental Clinical
Medical Laboratory Techniques
Anesthesia
Medical Documentation and Secretariat
Medical Imaging Techniques
Audiometry
Nuclear Medicine Techniques
First And Emergency Aid
Radioterapy

Course Objective

The aim of the course is to introduce the regulations covering the medical devices and their accessories on the topics of offering to use, presence in the market place, opening to use; the electronic safety and reliability of the data acquired and the safeguard of participant safety during clinical research, using medical devices.

Learning Outcomes of the Course Unit

1   Learns the foundations, basic concepts of healthcare law science and their relationships to other law sciences.
2   Learns the legal, classification, production and verification procedures related to medical devices.
3   Learns his/her rights and responsibilities and the how to behave acording to regulations and professional ethic rules.
4   Acquires knowledge about how to use the knowhow and skills obtained.

Mode of Delivery

Face -to- Face

Prerequisites and Co-requisites

None

Recomended Optional Programme Components

None

Course Contents

Week Subject Description
1 Introduction to the course.
2 Official or recognized national and international institutions, organizations and their authorities, servers related to medical devices.
3 Regulations for placing medical devices on the market and putting them into service.
4 Tasks and powers of the responsible persons defined in the Medical Devices Act.
5 Rules to be follows in relation to EU and other medical device standards.
6 Traceability, registration, safety and summary of clinical performance of medical devices, national and international product tracking systems.
7 Concepts of post-market surveillance, medical vigilance (ensuring field safety), surveillance and inspection.
8 Rechtsvorschriften über klinische Praktiken und Forschung
9 Midterm exam.
10 Requirements for a quality management system that can be used to design and provide services related to the design and development, manufacture and installation of medical devices.
11 Commonalities of quality management system standards, conformity assessment activities, relationships with ISO 9001 and other standards.
12 Quality Management System Legislation of the Ministry of Health and Hospital Inspections
13 Technical specification for medical devices preparation and purchase example application.
14 Case study to determine acceptance criteria for medical devices.
15 Case study for selection when installing medical equipment.

Recomended or Required Reading

Tıbbi Cihaz Yönetmeliği, Türkiye Ilaç ve Tıbbi Cihaz Kurumu,2021.
90/385/EEC ve 93/42/EEC Yönergesi, Avrupa Birliği Parlamentosu, 2017

Planned Learning Activities and Teaching Methods

Lectures and homeworks

Assessment Methods

SORTING NUMBER SHORT CODE LONG CODE FORMULA
1 AS ArasınavTeo
2 FCGR FINAL COURSE GRADE
3 FCG FINAL COURSE GRADE AS * 0.50 + FN * 0.50
4 RST RESIT
5 FCGR FINAL COURSE GRADE (RESIT) AS * 0.50 + BUT * 0.50


Further Notes About Assessment Methods

None

Assessment Criteria

To be announced.

Language of Instruction

Turkish

Course Policies and Rules

Class attendance is compulsory.

Contact Details for the Lecturer(s)

m.ates@deu.edu.tr

Office Hours

Monday 10:00-11:00

Work Placement(s)

None

Workload Calculation

Activities Number Time (hours) Total Work Load (hours)
Lectures 1 14 14
Preparation about subject 1 14 14
Preparation for midterm exam 1 4 4
Preparation for final exam 1 6 6
Midterm 1 1 1
Final 1 1 1
TOTAL WORKLOAD (hours) 40

Contribution of Learning Outcomes to Programme Outcomes

PO/LOPO.1PO.2PO.3PO.4PO.5PO.6PO.7PO.8PO.9PO.10PO.11PO.12PO.13PO.14PO.15PO.16PO.17PO.18
LO.13
LO.233
LO.34
LO.4333

CONTACT INFORMATION
Dokuz Eylül Üniversitesi Cumhuriyet Bulvarı No: 144 35210 Alsancak / İZMİR
Phone: +90(232) 412 12 12 - Fax: +90 (232) 464 81 35

Copyright 2015 DEÜ. BİD

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