Conformity assessment of personal protective equipment

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Conformity assessment of medical devices

Since 1 July 2015, it has been a mandatory requirement that medical devices, before being placed on the Ukrainian market and/or put into service, must be subject to the assessment of conformity with the Technical regulations (TR) (approved by Resolutions No. 753, 754, 755 of the CMU of 2 October 2013). Clause 21 of Resolution No. […]

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Education and training

The main specialization of the UNI-CERT Training Center is the advanced training of quality managers and regulatory managers of suppliers, distributors, manufacturers of medical devices and personal protective equipment. In addition, regular internal training of our own employees is carried out. In addition to the main topics that are in constant demand among most market […]

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Testing of the product characteristics

The National Accreditation Agency of Ukraine confirmed the technical competence of the UNI-CERT Testing Laboratory against DSTU ISO/IEC 17025:2017 General Requirements for the Competence of Testing and Calibration Laboratories (ISO/IEC 17025:2017, IDT) with an Accreditation certificate No. 201394 dated 20 April 2021). The laboratory’s scope of activities covers the testing of the following products: medical devices, namely […]

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