Сonsulting agency for conformity assessment, registration and certification of medical devices

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Our company has more than 10 years of experience in the registration of medical devices and IVD in Ukraine. We have dozens of successfully implemented projects in various fields of application. We are the company that provides results, along with an individual approach to each client and affordable prices for our services.


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More than 10 years

work experience

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Over 100 projects

were implemented

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Individual

approach to customers

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Loyal price

Company policy

Last news

Medical Device Regulation in Ukraine: Preparing for MDR and IVDR in 2025–2026

27.7.2025

Medical Device Regulation in Ukraine: Preparing for MDR and IVDR in 2025–2026

In 2025, Ukraine is actively preparing for a major reform of its regulatory framework for medical devices. The main objective is to align national...

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Clinical Evaluation of Medical Devices in Ukraine: Are Clinical Trials Really Necessary?

10.7.2025

Clinical Evaluation of Medical Devices in Ukraine: Are Clinical Trials Really Necessary?

All medical devices intended for placing on the Ukrainian or EU market must undergo clinical evaluation. This does not always mean conducting a clinical...

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Medical Device Market in Wartime Ukraine: Risks, Dynamics, Opportunities

14.6.2025

Medical Device Market in Wartime Ukraine: Risks, Dynamics, Opportunities

Introduction: War Doesn’t Stop the Market Despite full-scale war and ongoing economic challenges, Ukraine’s medical device market remains resilient and active. In 2025, procurement,...

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