Quality management of medical devices: we apply ISO 13485:2016 without errors

01.05.2021

Quality management // № 4 (40), April 2021

The text of the article is available only in Ukrainian

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30.09.2024

Conducting internal audits in accordance with the provisions of DSTU ISO 19011:2019

The program of the event is available only on Ukrainian

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02.11.2023

Medical devices and medical devices for in vitro diagnostics: fundamental differences

ThePharmaMedia The first independent pharmaceutical business portal. Medical devices and medical devices for in vitro diagnostics play a fundamental role in modern medicine. However, although both categories use the term “medical devices,” they have important differences in their purpose, use and regulation. The text of the article is available only in Ukrainian

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06.09.2021

Certification of medical device manufacturing by pharmaceutical companies

PROGRAM Nomenclature of medical devices in the “product portfolio” of pharmaceutical companies: medical devices supplied with a medicinal product medical devices for drug delivery products that are integral with the medicinal product products for IVD, RUO (research use only) and general laboratory equipment medical / cosmetic / hygienic purpose of products aids (accessories) Requirements of […]

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