COURSE UNIT TITLE

: LEGAL REGULATIONS AND SAFETY IN MEDICAL DEVICES

Description of Individual Course Units

Course Unit Code Course Unit Title Type Of Course D U L ECTS
SBE 5048 LEGAL REGULATIONS AND SAFETY IN MEDICAL DEVICES ELECTIVE 2 0 0 3

Offered By

The Institute Of Health Sciences

Level of Course Unit

Second Cycle Programmes (Master's Degree)

Course Coordinator

ASSOCIATE PROFESSOR AYŞEGÜL YURT

Offered to

Internal Medicine Nursing
Musculoskeletal Physiotherapy
Orthopaedic Physiotherapy
Geriatric Physiotherapy
Medical Biology and Genetics
Nursing Management
Neurological Physiotherapy- Rehabilitation
Language and Speech Theraphy
Physical Therapy and Rehabilitation
Biochemistry
Oncology Nursing
Basic Oncology
COMMUNITY HEALTH NURSING
Clinical Neuroscience
Radiopharmaceutical Sciences
Biophysics
Microbiology
Audiology
Biomechanics
Basic Neuroscience
Cardiopulmonary Physiotherapy
Perfusion Techniques
Translational Oncology
CLINIC SLEEP AND STATES OF CONSCIOUSNESS
Physical Therapy and Rehabilitation
Obstetrics and Gynaecology Nursing
Medical Informatics
Molecular Medicine
Movement and Training Sciences
Pediatric Nursing
PROSTHESIS AND ORTHOSIS
Public Health
Anatomy
Medical Education
BASIC SLEEP AND STATES OF CONSCIOUSNESS
QUALITY IMPROVEMENT AND ACCREDITATION IN HEALTH CARE
Surgical Nursing
Histology and Embryology
CLINICAL DRUG RESEARCH
Medical Physics
Medical Parasitology
PHYSIOLOGY
Pharmacology
Psychiatric Nursing
Exercise Physiology
Dental Biomaterials
Laboratory Animal Science
Toxicology
TRANSLATIONAL MEDICINE
Fundamentals of Nursing
OCCUPATIONAL HEALTH NURSING
CANCER APIDEMIOLOGY

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

Mode of Delivery

Face -to- Face

Prerequisites and Co-requisites

None

Recomended Optional Programme Components

None

Course Contents

Week Subject Description

Recomended or Required Reading

To be announced.

Planned Learning Activities and Teaching Methods

Assessment Methods

SORTING NUMBER SHORT CODE LONG CODE FORMULA
1 MTE MIDTERM EXAM
2 PRF PERFORMANCE
3 FIN FINAL EXAM
4 FCGR FINAL COURSE GRADE MTE * 0.30 + PRF* 0.30 + FIN* 0.40
5 RST RESIT
6 FCGR FINAL COURSE GRADE (RESIT) MTE * 0.30 + PRF* 0.30 + RST* 0.40


Further Notes About Assessment Methods

None

Assessment Criteria

To be announced.

Language of Instruction

Turkish

Course Policies and Rules

To be announced.

Contact Details for the Lecturer(s)

To be announced.

Office Hours

To be announced.

Work Placement(s)

None

Workload Calculation

Activities Number Time (hours) Total Work Load (hours)
TOTAL WORKLOAD (hours) 0

Contribution of Learning Outcomes to Programme Outcomes

PO/LOPO.1PO.2PO.3PO.4PO.5PO.6PO.7PO.8PO.9PO.10PO.11PO.12