Ukrainian Scientific Institute of Certification

Ukrainian Scientific Institute of Certification is a modern and competent notified body for the conformity assessment of medical devices and medical devices for in vitro diagnostics. We are also accredited to conduct certification according to the international standards ISO 9001, ISO 13485 (medical devices) and ISO 22716 (GMP for cosmetic products).

Our key advantages:

√  Over 400 international manufacturers of medical devices from 37 countries have already entrusted us with the conformity assessment of their products;

√  A strong professional team that conducts audits and examination of documentation in English and German;

√  Cooperation with leading European notified bodies and testing laboratories, which ensures the recognition of the results of conformity assessment and documentation.

We combine deep regulatory expertise, international experience and a practical approach to certification, which makes us a reliable and long-term certification partner for the development of your business.

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We are trusted

by more than 400 international medical device manufacturers since:

• Our team consists of 39 full-time and 20 freelance specialists
• Our experience is more than 700 audits in 37 countries in Ukrainian, Russian, English and German languages
• We have entered into Agreements on recognition of conformity assessment results with leading European notified bodies