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Management and design of medical devices

Anotace

The subject will deepen and consolidate knowledge of quality assurance and control procedures and their use in the development and production of medical devices. This subject will promote an understanding of the importance of user-centred design principles in the development of medical devices, promote the use of best practices in project management, including project planning, resource allocation and risk mitigation. The course will focus on a deeper understanding of interdisciplinary collaboration in the design and development of medical devices, such as communication between engineers, physicians, regulatory experts and other stakeholders involved in the development and commercialization of medical devices. The course will emphasize understanding the importance of innovation and creativity in the development of medical devices, to think critically and creatively about the design and development process in relation to the use of new technologies and materials. Students' communication and presentation skills will also be developed, including the ability to effectively communicate technical information to a variety of audiences such as investors, regulatory authorities and healthcare providers.

Povinná literatura

1. ISO 13485:2016 Medical devices — Quality management systems — Requirements for regulatory purposes
2. REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC

Presentation from lectures

Doporučená literatura

1. Fries, R. C. (2012). Reliable design of medical devices. CRC Press.
2. Prutchi, D., & Norris, M. (2005). Design and development of medical electronic instrumentation: a practical perspective of the design, construction, and test of medical devices. John Wiley & Sons.
3. Weinger, M. B., Wiklund, M. E., & Gardner-Bonneau, D. J. (Eds.). (2010). Handbook of human factors in medical device design. CRC Press.


Language of instruction čeština, angličtina
Code 660-2017
Abbreviation MDZP
Course title Management and design of medical devices
Coordinating department Centre for Advanced Innovation Technologies
Course coordinator Ing. Lukáš Peter, Ph.D.