Ukrainian Scientific Institute of Certification

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; […]

Cosmetic product safety: production regulation

Quality management // № 1-2 (49-50), January 2022 Guaranteeing the safety of products for consumers is a very important component of the image of cosmetics manufacturers. The leading motivation for the transition to work on GMP will be the standardization of production processes and the implementation of measures that make it possible to produce high-quality, […]

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 […]

Conformity assessment requirements for subcontracting manufacture (OBL-OEM). Technical file structure.

The program of the event is available only on Ukrainian or Russian