Safety of handling of medical devices at all stages of their life cycle
https://doi.org/10.21045/2782-1676-2021-2-3-16-24
Abstract
The review describes the main points of the life cycle of a medical device, considers three stages of regulation of medical devices: pre-market, market and post-sale. The main attention is paid to post-sale supervision, as an activity for monitoring used medical devices, collecting information about the quality, safety and effectiveness of medical devices.
About the Authors
E. V. Zinovyeva
National Quality Institute of Roszdravnadzor
Russian Federation
Russian Federation
Evgeniya V. Zinovyeva – teacher of the educational and methodological department
Moscow
A. V. Sapunova
FGBU «VNIIIMT» of Roszdravnadzor
Russian Federation
Russian Federation
Anna V. Sapunova – Head of the Center for monitoring the Safety of Medical Devices, examination of Medical Devices, inspection of the Production of Medical Devices
Moscow
I. V. Ivanov
FGBU «VNIIIMT» of Roszdravnadzor
Russian Federation
Russian Federation
Igor V. Ivanov – Director, Dr. of Sci. (Medicine)
Moscow
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Review
For citations:
Zinovyeva E.V., Sapunova A.V., Ivanov I.V. Safety of handling of medical devices at all stages of their life cycle. Public Health. 2022;2(3):16-24. (In Russ.) https://doi.org/10.21045/2782-1676-2021-2-3-16-24
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