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

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

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.9