BMM465

School of Engineering \ Biomedical Engineering

3

6

Elective

English

-

Department of Biomedical Engineering Department

Information is provided on what a medical device is, the production processes of medical devices, ethical committee approvals, the operation of medical devices, maintenance, repair, and calibration processes, as well as quality certifications.

Regulations and Directives of the Turkish Medicines and Medical Devices Agency

This course aims to identify all medical devices included in the biomedical field and examine the regulations applied during the production, operation, and use of these medical devices both nationally and internationally.

1. Gain knowledge of the regulations of the Turkish Medicines and Medical Devices Agency (TMMDA).
2. Understand the directives and regulations issued by the Turkish Medicines and Medical Devices Agency.
3. Acquire information about the necessary processes for clinical research and ethical committee approvals for medical devices.

1 Week: Turkish Medicines and Medical Devices Agency
2 Week: Medical Devices
3 Week: Clinical Research on Medical Devices
4 Week: Medical Device Production Centers
5 Week: Notified Bodies for Medical Devices
6 Week: Medical Device Regulation
7 Week: Midterm Exam
8 Week: Regulation on Active Implantable Medical Devices
9 Week: Ethical Committees
10 Week: Regulation on the Sale, Advertising, and Promotion of Medical Devices
11 Week: Medical Device Quality Management System
12 Week: Regulation on the Testing, Control, and Calibration of Medical Devices