News

21.05.2021

The 10th anniversary Ukrainian forum of medical device market operators was held

On May 14, the 10th anniversary Ukrainian forum of medical device market operators took place, which traditionally provides manufacturers, suppliers, distributors, importers of medical devices with a platform for communication and exchange of valuable business experience. Ukrainian Scientific Institute of Certification was a partner of this event. In addition, Anna Telpiakova, First Deputy Director of […]

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17.05.2021

UNI-CERT extended the field of activity of its Testing Laboratory

Once again, the Ukrainian Scientific Institute of Certification has extended the accreditation scope of its Testing Laboratory UNI-CERT LLC, and this time by 23 standards and 127 test indicators in the field of Personal Protective Equipment (PPE). According to the accreditation certificate No. 201394 and number of additions to the accreditation scope, the Testing Laboratory […]

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01.05.2021

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

Quality management // № 4 (40), April 2021 The text of the article is available only in Ukrainian

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15.04.2021

Documents required for legal placement of medical devices on the market. Market surveillance.

PROGRAM Temporary changes in the rules of import of medical devices and personal protective equipment needed to prevent the COVID-19 Conformity assessment procedures: self-declaration or assessment with the involvement of a designated body Requirements for accompanying documentation: labeling, instructions for use, declaration of conformity Application of the requirements of the Law of Ukraine “On ensuring […]

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12.04.2021

Certification of medical devices during a pandemic. Remote audits, recognition of conformity assessment results, held outside Ukraine

The Ukrainian Scientific Institute of Certification invites you to take part in the 10th anniversary Ukrainian forum of medical device market operators, within the framework of which our specialists will make a report on the topic: “Certification of medical devices during a pandemic: remote audits, recognition of the results of conformity assessment carried out outside […]

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23.02.2021

A contract on recognition of the results of the assessment of conformity with Polish Centre for Testing and Certification (1434)

We are pleased to inform you that the notified body Polish Centre for Testing and Certification (1434) 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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