Remote audits of global manufacturers of medical devices

20.09.2021

Journal “Laboratory” No. 08/2020

The text of the article is available only in Ukrainian

Other news

15.04.2022

Conformity assessment requirements for subcontracting manufacture (OBL-OEM). Technical file structure.

The program of the event is available only on Ukrainian or Russian

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23.01.2020

Guidelines for medical devices

The Ministry of Health of Ukraine approved guidelines that are developed on the basis of relevant documents of the European Commission (MEDDEV) for an unambiguous interpretation of technical regulations regarding medical devices, medical devices for in vitro diagnostics and active implantable medical devices. The recommendations are not legally binding, but should be taken into account […]

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28.10.2021

Main requirements of ISO 13485:2018. Risk management according to DSTU EN ISO 14971:2015.

The program of the event is available only on Ukrainian or Russian

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