Certification of Medical Devices

Certification of Medical Devices
450-4074/01
čeština Certification of Medical Devices
450-4074/02
angličtina

Summary

The subject "Certification of Medical Devices" will deepen the basic information on legislation related to medical devices - ZP. The lessons are focused on a deeper understanding of the ISO work related to the ZP and, to a large extent, on the certification of the ZP from the point of view of the manufacturer, but also partly from the point of view of medical devices. From the point of view of the necessary procedures and requirements for certification of the ZP, all necessary documents necessary for conformity assessment by the notified body are discussed in the EU and also outside the EU as well as the individual procedures for the creation of such documents.

Literature

Presenattion of lectures
MDR 2017/745.The EU Medical Devices Regulation, 2017, 175 p.
LEPAKHIN, K. V. Medical Device Regulations–Global Overview and Guiding Principles. WHO, Geneva, 2003.

Advised literature

ISO 13485:2016. Medical devices -- Quality management systems -- Requirements for regulatory purposes. International Organization for Standardization, 2016. 36 p.
ISO 14971:2007. Medical devices -- Application of risk management to medical devices. International Organization for Standardization, 2007. 82 p.
COUNCIL DIRECTIVE 93/42/EEC concerning medical devices, 1993, 58 p.
Another regulatory documents

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Language of instruction	čeština, angličtina
Code	450-4074
Abbreviation	CZP
Course title	Certification of Medical Devices
Coordinating department	Department of Cybernetics and Biomedical Engineering
Course coordinator	Ing. Lukáš Peter, Ph.D.