COURSE UNIT TITLE

: STANDARD OF MEDICAL DEVICES I

DEGREE PROGRAMMES

Description of Individual Course Units

Course Unit Code Course Unit Title Type Of Course D U L ECTS
SKA 5073 STANDARD OF MEDICAL DEVICES I ELECTIVE 1 2 0 3

Offered By

QUALITY IMPROVEMENT AND ACCREDITATION IN HEALTH CARE

Level of Course Unit

Second Cycle Programmes (Master's Degree)

Course Coordinator

PROFESSOR DOCTOR ABDURRAHMAN HÜSEYIN BASKIN

Offered to

QUALITY IMPROVEMENT AND ACCREDITATION IN HEALTH CARE

Course Objective

To provide medical devices and medical devices, and consistent with the needs of the patient-related services on a regular basis the terms of applicable legislation in order to meet the terms of the ability to prove the quality management is important for an organization. The main purpose of the course, the quality management schemes to facilitate harmonized medical device legislation requirements,

Learning Outcomes of the Course Unit

1   To recognize and remember the concept of medical devices standards
2   The concept of medical devices standards are expected to be able to express in their own words.
3   Using the information on the concept of medical devices standards are expected to solve different problems
4   To express the reasons for the concept of medical devices standards; conclusions and generalizations see, is expected to see the evidence that supports them, and rejection.
5   Medical devices standards License synthesis of the concept of the student is expected to know exactly the required information and are not permitted to estimates by chance, to have exactly the information that the student is expected to provide creative answer
6   Evaluation of the concept of medical devices standards using the student's own knowledge and ideas, the answer is - the process - the method - and the decision about the outcome of this decision is expected to defend.

Mode of Delivery

Face -to- Face

Prerequisites and Co-requisites

None

Recomended Optional Programme Components

None

Course Contents

Week Subject Description
1 Scope of the standard, the Quality Management System
2 General Terms, Conditions of Documentation
3 Management's Responsibility: Management commitment, patient-oriented
4 Management's Responsibility: Quality Policy, Planning
5 Management's Responsibility: Responsibility, Authority and Communication
6 Analysis of the sample (group presentations)
7 Mid term exam
8 Management's Responsibility: Management Review
9 Product Realization: Planning, Patient-Related Processes
10 Product Realization: Design and development
11 Product Realization: Purchasing
12 Product Realization: Product and Service Submission
13 Product Realization: Control of Monitoring and Measuring Devices
14 Analysis of the sample (group presentations)
15 TS EN 13485 for comparison with other standards
16 Final exam

Recomended or Required Reading

Textbook(s): Lecture notes
www.iso.org
Supplementary Book(s):
www.who.org
www.turkak.org.tr
www.tse.org.tr
1. Nihat KÖLÜK, Irfan DILSIZ, Cafer S. KARTAL. Kalite Güvencesi ve Standartları. Detay Yayıncılık, 6. Baskı 2011.
2. Prof. Dr. Canan ÇETIN. Toplam Kalite Yönetimi: Ilke, Süreç, Uygulama. Beta Yayıncılık. ISTANBUL, 3. Baskı 2010.
3. Dr. Özlem YILDIRIM: Sağlık Kuruluşlarında Insan Faktörü Mühendisliğinin önemi ve Hasta Güvenliği Alanında Uygulama Örnekleri. Beta Yayıncılık. ISTANBUL, 1. Baskı 2012
4. Edt: Prof. Dr. Nilgün SARP, Av. Cahid DOĞAN. III. Sağlık Hakkı ve Sağlık Hukuku Sempozyumu. 25- 26 Nisan 2011. Kuzey Kıbrıs Türk Cumhuriyeti Lefke Avrupa Üniversitesi. Adalet Yayınevi, 2012-08-13

Planned Learning Activities and Teaching Methods

Presentation, question and answer, sample analysis, group work.

Assessment Methods

SORTING NUMBER SHORT CODE LONG CODE FORMULA
1 PRF PERFORMANCE
2 FIN FINAL EXAM
3 FCG FINAL COURSE GRADE PRF * 0.40 + FIN*0.60
4 RST RESIT
5 FCGR FINAL COURSE GRADE (RESIT) PRF * 0.40 + FCGR*0.60


*** Resit Exam is Not Administered in Institutions Where Resit is not Applicable.

Further Notes About Assessment Methods

None

Assessment Criteria

1. Note that the boundary between the two groups participated in the study notes, note, carry a higher level.
2. Sample analysis will be made in the form of a group. Distribution of tasks within the group and the group's responsibility to ensure equal participation of each group member. Marking of the sample analysis, faculty members and by the end of the semester, all students will be held to be explained.
3. Sample analysis, field research, and presentations, the subject has been expressed clearly in the relevant standards, and the findings on the basis of the originality of the discussion of the results, accuracy, comprehensiveness of the report content and presentation of the depth of analysis and mechanics and visual presentation, such as the timing of the operation-judged out of compliance.

Language of Instruction

Turkish

Course Policies and Rules

1. 70% of the courses required to attend.
2. All types of plagiarism will result in disciplinary action and actual attempts.

Contact Details for the Lecturer(s)

tonay.inceboz@gmail.com

Office Hours

during working day

Work Placement(s)

None

Workload Calculation

Activities Number Time (hours) Total Work Load (hours)
Lectures 14 2 28
Tutorials 14 1 14
Preparations before/after weekly lectures 14 1 14
Preparation for midterm exam 1 3 3
Preparation for final exam 1 3 3
Preparing assignments 1 3 3
Preparing presentations 1 5 5
Final 1 1 1
Midterm 1 1 1
TOTAL WORKLOAD (hours) 72

Contribution of Learning Outcomes to Programme Outcomes

PO/LOPO.1PO.2PO.3PO.4PO.5PO.6PO.7PO.8PO.9PO.10
LO.15543334345
LO.25543334345
LO.35443434345
LO.45443434345
LO.55443454345
LO.65443454345

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

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