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Legislation and Medical Technology Management

Summary

The subject "Legislation and management of medical technology" will provide basic and information on the use of medical devices in terms of valid legislation. The course focuses on the internal structure and function of the healthcare facility, on technical development and investment activities, on medical devices - ZP - their division according to a number of views, compilation of investment plans with acquisition of ZP, cooperation of technicians ensuring and guaranteeing correct and safe use of ZP in providing health care, the entire administration and records of the PA. The subject acquaints with the laws applicable to the use and management of the ZP, with the technical standards for ZP instrumentation, with the standards for construction of ZP, the metrology law, the quality management system from the point of view of the medical device, as well as from the point of view of the manufacturers of medical technology.

Literature

Presentation 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


Language of instruction čeština, angličtina
Code 450-2066
Abbreviation LMZT
Course title Legislation and Medical Technology Management
Coordinating department Department of Cybernetics and Biomedical Engineering
Course coordinator Ing. Lukáš Peter, Ph.D.