Сonsulting agency for conformity assessment, registration and certification of medical devices
Need registrationOur 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.
More than 10 years
work experience
Over 100 projects
were implemented
Individual
approach to customers
Loyal price
Company policy
Last news
24.11.2025
Post-Market Surveillance Under EU MDR: Understanding PMS, PMCF and PSUR
Under the EU Medical Device Regulation (EU MDR 2017/745), every manufacturer placing a medical device on the EU market must implement a comprehensive post-market...
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31.10.2025
Changing the Authorised Representative in Ukraine: What Manufacturers Should Know
Over the past two weeks, several manufacturers contacted us regarding the change of their Authorised Representative (AR) in Ukraine. In most cases, the reason...
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24.9.2025
Medical Devices and Other Technical Regulations: When MDR/IVDR Alone Is Not Enough
1. Multi-level regulation By definition, a medical device must comply with the technical regulations in the field of medical devices (in Ukraine: TRs No....
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