Documenting the quality management system for the production of medical products according to ISO 13485:2018

01.06.2021

Quality management // № 5 (41), May 2021

The text of the article is available only in Ukrainian

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26.08.2021

Medical devices in the nomenclature of pharmaceutical manufacturers. Conformity assessment of in-vitro diagnostic medical devices

PROGRAM Devices at the border of definitions: medical devices supplied with the medicinal product; medical devices as a means of drug delivery; devices, an integral part of which is a medicinal product; devices for IVD, RUO (research use only) and general laboratory equipment. Conformity assessment through self-declaration. Conformity assessment performed by conformity assessment body: choosing […]

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23.06.2020

Production of sterile medical devices: Clean rooms

Journal “Laboratory” No. 06/2020 The text of the article is available only in Ukrainian

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14.07.2023

A contract on recognition of the results of the assessment of conformity with SGS Belgium NV (ID 1639)

We are pleased to inform you that the notified body SGS Belgium NV (ID 1639) has signed an arrangement for the recognition of conformity assessment results with the UNI-CERT LLC. Due to this collaboration, our clients can significantly reduce their time and financial expenses for certification of their products in Ukraine. We have already accumulated sufficient […]

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