Courses – Fakultet tehničkih nauka u Novom Sadu

Subject: Design of medical devices (17.E1PS5B)

Type of studies	Title
Master Academic Studies	Biomedical Engineering (Year: 1, Semester: Winter)

General information:

Category	Professional-applicative
Scientific or art field	Električna merenja, metrologija i biomedicina
ECTS	6

Acquiring knowledge in the field of design and development of medical devices.

Understanding basic principles in design and development of medical instruments and systems. Ability to perform an effective literature search and to utilize other types of information sources in the field of design and development of medical instruments and systems. Ability to present results of the research. Ability to work in a multidisciplinary team environment with biomedical engineers and doctors on the problem solving related to design, development and manufacturing of medical instruments and systems. Ability to perform every step of design and development of medical instruments and systems.

Design, development and production of medical devices in accordance with the requirements of the standards for the quality of medical devices ISO 13485. Life cycle of a medical device: conceptual concept, design and development, production, service and maintenance, end of use and recycling of the device. Choosing chapters from one or more of the following sub-areas: Designing medical devices and analog modules; design of medical devices and digital modules; design of medical devices and microprocessors; design of medical devices and microcontrollers; design of medical devices and software; design of medical devices and the Internet; design of medical devices and information systems; designing medical smart devices; design of medical devices and wireless sensory systems.

Lectures, auditory exercises, labaratory exercises, consultations.

Authors	Title	Year	Publisher	Language
R. C. Fries	Reliable Design of Medical Devices	1997	CRC Press	English
ISO TC 210	ISO 14971:2007 Medical devices -- Application of risk management to medical devices	2007	International Organization for Standardization	English
R. C. Fries	Handbook of Medical Device Design	2001	CRC Press	English
ISO TC 210	ISO 13485:2003 Medical devices -- Quality management systems -- Requirements for regulatory purposes	2003	International Organization for Standardization	English
B. El-Haik, K. S. Mekki	Medical Device Design for Six Sigma: A Road Map for Safety and Effectiveness	2011	Wiley-Interscience	English