Ukrainian Scientific Institute of Certification

In connection with the military aggression of the Russian Federation in Ukraine martial law was imposed from 05 hours 30 minutes on February 24, 2022 for 30 days in accordance with the Law of Ukraine dated February 24, 2022 No. 2102-IX “On approval of the Decree of the President of Ukraine “On the imposition of martial law in Ukraine”.

The appointed conformity assessment body Uni-Cert LLC announces the introduction of business continuity planning measures aimed at minimizing risks for customers and employees while maintaining all critical business processes. Our team has moved to remote work has access to the Internet and do everything possible to support work processes.

At the same time, the Chamber of Commerce and Industry of Ukraine confirms that these circumstances from February 24, 2022 to their official end are extraordinary, unavoidable and objective circumstances that prevent the implementation of contracts and regulations due to force majeure.

Accordingly, part of the planned work primarily surveillance procedures, are performed on schedule. Certain adjustments are possible.

The term of all other works, in accordance with the section “Force Majeure” of the agreements, has been extended for a period equal to the term of military aggression of the Russian Federation against Ukraine established by law.

At the same time Uni-Cert LLC does not waive its obligations in any way full-fledged work will be resumed as soon as possible.

Ukraine’s healthcare system is stable. The coordinated work of public authorities as well as enterprises, institutions and organizations belonging to the sphere of their management is a significant contribution to ensuring the rights and freedoms of Ukrainian citizens and unites us in the face of the enemy.

We hope for mutual understanding and further fruitful cooperation.

Glory to Ukraine!

Sincerely,

Director of Uni-Cert LLC

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

09.06.202210.00-14.00
09.06.2022

Conformity assessment for I class medical devices and some devices for IVD. Technical file structure.

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16.06.202210.00-14.00
16.06.2022

Development and implementation of a quality management system ISO 9001

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23.06.202214.30-18.00
23.06.2022

Medical devices in the nomenclature of pharmaceutical manufacturers

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News

05.05.2022

Free laboratory tests to support the Armed Forces of Ukraine and humanitarian aid!

Dear volunteers, friends, colleagues! The Ukrainian Scientific Institute of Certification has its own accredited testing laboratory, which provides laboratory testing for compliance with the requirements of 49 international and domestic standards for 146 test methods for medical devices and personal protective equipment. If you or your partners need to conduct laboratory tests of products supplied […]

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15.04.2022

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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24.01.2022

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, […]

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