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

31.07.2023

Management of the healthcare institution No. 7 July 2023

The text of the article is available only in Ukrainian

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24.06.2020

Comparison of sterilization methods

Journal “Laboratory” No. 07/2020 The text of the article is available only in Ukrainian  

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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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29.12.2021

The Pharmacy weekly # 50 has published a review article about our Digest-Seminar 2021

On December 16, the final Digest-seminar “The most important regulatory changes in the field of medical devices 2021” was held, the speaker of which was Victoria Shevchenko, head of the conformity assessment department of UNI-CERT LLC. During the seminar, the impact of the updated requirements for cosmetics on the field of medical devices, new European […]

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