Analysis of real-world data for medical device evaluation: Chinese manual

Real-word data obtained using medical devices differ from the use of drugs. When using medical devices, the effectiveness is usually not in doubt, and the issues of biocompatibility, safety, and long-term use come to the fore. This article presents a translation of the clinical guidelines of the Peo...

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Main Authors: A. R. Kasimova, Wenlong Zhao
Format: Article
Language:Russian
Published: Publishing House OKI 2024-09-01
Series:Реальная клиническая практика: данные и доказательства
Subjects:
Online Access:https://www.myrwd.ru/jour/article/view/68
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author A. R. Kasimova
Wenlong Zhao
author_facet A. R. Kasimova
Wenlong Zhao
author_sort A. R. Kasimova
collection DOAJ
description Real-word data obtained using medical devices differ from the use of drugs. When using medical devices, the effectiveness is usually not in doubt, and the issues of biocompatibility, safety, and long-term use come to the fore. This article presents a translation of the clinical guidelines of the People’s Republic of China on planning and conducting studies on the use of medical devices in real-world clinical practice, as well as statistical processing of the information obtained in an abbreviated form.
format Article
id doaj-art-07dfb9ff99c542d9a2b0edd053bd3a5d
institution DOAJ
issn 2782-3784
language Russian
publishDate 2024-09-01
publisher Publishing House OKI
record_format Article
series Реальная клиническая практика: данные и доказательства
spelling doaj-art-07dfb9ff99c542d9a2b0edd053bd3a5d2025-08-20T03:19:12ZrusPublishing House OKIРеальная клиническая практика: данные и доказательства2782-37842024-09-0142132110.37489/2782-3784-myrwd-5357Analysis of real-world data for medical device evaluation: Chinese manualA. R. Kasimova0Wenlong Zhao1First Saint Petersburg State Medical University St. Petersburg; R.R. Vreden National Medical Research Center of Traumatology and OrthopedicsSinopharm GroupReal-word data obtained using medical devices differ from the use of drugs. When using medical devices, the effectiveness is usually not in doubt, and the issues of biocompatibility, safety, and long-term use come to the fore. This article presents a translation of the clinical guidelines of the People’s Republic of China on planning and conducting studies on the use of medical devices in real-world clinical practice, as well as statistical processing of the information obtained in an abbreviated form.https://www.myrwd.ru/jour/article/view/68real-world datamedical devicesguidelinesmedical device evaluationchina
spellingShingle A. R. Kasimova
Wenlong Zhao
Analysis of real-world data for medical device evaluation: Chinese manual
Реальная клиническая практика: данные и доказательства
real-world data
medical devices
guidelines
medical device evaluation
china
title Analysis of real-world data for medical device evaluation: Chinese manual
title_full Analysis of real-world data for medical device evaluation: Chinese manual
title_fullStr Analysis of real-world data for medical device evaluation: Chinese manual
title_full_unstemmed Analysis of real-world data for medical device evaluation: Chinese manual
title_short Analysis of real-world data for medical device evaluation: Chinese manual
title_sort analysis of real world data for medical device evaluation chinese manual
topic real-world data
medical devices
guidelines
medical device evaluation
china
url https://www.myrwd.ru/jour/article/view/68
work_keys_str_mv AT arkasimova analysisofrealworlddataformedicaldeviceevaluationchinesemanual
AT wenlongzhao analysisofrealworlddataformedicaldeviceevaluationchinesemanual