ID: 3612
Course type: scientific and vocational
Course coordinator: Matija R. Lidija
Lecturers: Matija R. Lidija
Contact: Matija R. Lidija
Level of studies: Ph.D. (Doctoral) studies – Mechanical Engineering
ECTS: 5
Final exam type: project design
The aim of the course is to introduce in details MDR and iVDR, as well as with state regulations related to medical devices. The programme developed further knowledge obtained within the course in Clinical engineering. Detailed information will be given on medical metrology, risk management and management of the medical devices.
Students will be educated to provide full support and logistic in the medical institutions.
Theoretical classes include getting acquainted with the legislative system in Serbia and the European Union.
Depending on the sub-area chosen by the doctoral student, as well as the project, the training will be conducted within one of the hospitals, clinical or rehabilitation centers, as well as other services operating in the field of health.
Enrolled doctoral studies.
Professional literature and equipment depending on the selected subfield.
Total assigned hours: 65
New material: 30
Elaboration and examples (recapitulation): 20
Auditory exercises: 0
Laboratory exercises: 0
Calculation tasks: 0
Seminar paper: 0
Project: 0
Consultations: 0
Discussion/workshop: 0
Research study work: 0
Review and grading of calculation tasks: 8
Review and grading of lab reports: 7
Review and grading of seminar papers: 0
Review and grading of the project: 0
Test: 0
Test: 0
Final exam: 0
Activity during lectures: 10
Test/test: 0
Laboratory practice: 30
Calculation tasks: 0
Seminar paper: 0
Project: 30
Final exam: 30
Requirement for taking the exam (required number of points): 50
Clinical engineering handbook, ed. Ernesto Iadanza, Academic Press, 2019, ISBN978-0-12-813467-2, doi: https://doi.org/10.1016/C2016-0-04298-5; Бјелица, Б. Бугарски, Л. Maтија, Б. Олујић, Д. Кичеић, K. Трифковић, Б.Баланц, Развој фармацеутских производа-смернице, QRIOT N.O., Београд 2018, (ISBN 978-86-920355-6-2); П. Ковачевић, Медицинска метрологија: Метролошки надзор пацијената, QRIOT N.O., Београд 2017, (ISBN 978-86-920355-5-5)