MGMD 101 – Regulation of Medical Devices and Diagnostics
Course lecturer :
Doaa Talha Gebreel
Course assistant :
- Eng Jouseff Adel
- Eng.Abd Allah Yousry
Course objectives :
1) Understand an overview of the historical development.
2) Recognize the development of medical devices and diagnostic techniques, including aspects of medical devices regulation and of product development.
3) Recognize the current status of the laws, regulations and guidelines governing medical devices.
Course description :
This course will introduce the students to the Quality System Regulation in the medical devices and biotech industries. Topics covered will include not only the legal requirements for Food, Drug and Cosmetic but also how to develop practical applications in order to demonstrate compliance. This course provides the knowledge and skills needed for the development of medical devices and diagnostic techniques, including aspects of medical product regulation and of product development.
Course assessment :
Assignments – Mid-term exam – Final exam Practical exam Field project
Recommended text books :
Medical Devices Regulation, Global Overview and guiding principles. Fredric M. Michele .2013
Recommended refrences :
2. Medical Device Development. One D. Salyn 2nd Edition 2013