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

07.10.202110.30-12.00
07.10.2021

Regulatory requirements for medical devices in laboratory practice

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07.10.202115.00-17.00
07.10.2021

Certification of medical device manufacturing by pharmaceutical companies

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20.10.202114.30-18.00
20.10.2021

Medical devices in the nomenclature of pharmaceutical manufacturers. Conformity assessment of in-vitro diagnostic medical devices

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News

20.09.2021

Remote audits of global manufacturers of medical devices

Journal “Laboratory” No. 08/2020 The text of the article is available only in Ukrainian

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06.09.2021

Certification of medical device manufacturing by pharmaceutical companies

PROGRAM Nomenclature of medical devices in the “product portfolio” of pharmaceutical companies: medical devices supplied with a medicinal product medical devices for drug delivery products that are integral with the medicinal product products for IVD, RUO (research use only) and general laboratory equipment medical / cosmetic / hygienic purpose of products aids (accessories) Requirements of […]

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26.08.2021

Regulatory requirements for medical devices in laboratory practice

PROGRAM Classification: medical device for IVD, RUO (research use only) and general laboratory equipment. Conformity assessment through self-declaration Conformity assessment performed by conformity assessment body: choosing the best procedure for your business application and documentation step-by-step description of the conformity assessment procedure through an audit of the manufacturing facilities special procedure for III class devices, […]

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