News

14.09.2023

Recognition of EU certificates for medical devices: prospects and opportunities

Quality management // № 09 / 2023, September The procedure for assessing the conformity of medical devices through the recognition of EU certificates is one of the possible ways to introduce medical devices into circulation in conditions of war, pandemic or other force majeure circumstances that prevent conformity assessment bodies from conducting regular assessment procedures […]

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04.09.2023

The 12th Ukrainian Forum of Medical Devices Market Operators was held

On August 31, the 12th Ukrainian Forum of Medical Devices Market Operators was held, which provided manufacturers, suppliers, distributors, and importers of medical devices with a platform for solving all urgent issues, discussions, recommendations, and sharing valuable experience in doing business during martial law. The Ukrainian Scientific Institute of Certification traditionally sponsored this event. In […]

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30.08.2023

Standard ISO 22716 “Cosmetics. Good Manufacturing Practice (GMP)”

On September 21, 2023, the XVIII specialized conference “BEAUTY TECH. INNOVATIONS IN PRODUCTION: RAW MATERIALS AND TECHNOLOGIES”, at which Tetyana Remzhina, head of the department of the accredited body “UNI-CERT”, will make a report on the topic: “Standard ISO 22716 “Cosmetics. Good Manufacturing Practice (GMP)”. During this report, listeners will be able to receive information […]

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25.08.2023

New MDR and ISO 13485 requirements for a distributor of a foreign manufacturer

The Ukrainian Scientific Institute of Certification invites you to take part in the 12th Ukrainian Forum of Medical Devices Market Operators®. In this difficult period for our country, more than ever, it is necessary to be aware of the latest key changes in the functioning of the medical device market. Therefore, the Ukrainian Forum of […]

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31.07.2023

How to implement a quality management system according to DSTU EN ISO 13485:2018 in the central sterilization department

Management of the healthcare institution No. 7 July 2023 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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