Ukrainian Scientific Institute of Certification

is a modern, competent body, which comply with all aspects of Ukrainian legislation and is guided by EU law. The body is completely independent and impartial in its decisions which are based solely on objective evidence of conformity.

Our services

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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Conformity assessment of personal protective equipment

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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; […]

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We are trusted

by more than 350 international medical device manufacturers since:

  • Our team consists of 39 full-time and 20 freelance specialists
  • Our experience is more than 500 audits in 35 countries in Ukrainian, Russian, English and German languages
  • We have entered into Agreements on recognition of conformity assessment results with leading European notified bodies
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Upcoming events

09.12.202110.00-12.00
09.12.2021

Conformity assessment of personal protective equipment in accordance with the new Technical Regulations No. 771

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16.12.202110.00-14.00
16.12.2021

The most important regulatory changes in the medical device industry. Digest 2021.

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27.01.202210.00-14.00
27.01.2022

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

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News

01.11.2021

The most important regulatory changes in the medical device industry. Digest 2021.

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01.11.2021

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

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

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29.10.2021

Conformity assessment of personal protective equipment in accordance with the new Technical Regulations No. 771

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