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. […]

Conformity assessment of personal protective equipment

Quality Management System Certification

The presence of a certified Quality Management System (QMS) provides the company with a number of advantages: The efficiency and effectiveness of processes are optimized and increased; The quality of products and/or services improves; The company becomes one that independently improves and develops, requires less attention from the company’s management; The effectiveness of decision-making increases; […]

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 […]

Information services

The Ukrainian Scientific Institute of Certification provides information services exclusively within its competence related to medical devices, personal protective equipment and certification of quality management systems. Thanks to the experience of cooperation with the largest suppliers and manufacturers on the Ukrainian market, concluded agreements on the recognition of the conformity assessment results with leading European […]

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 […]