In Vitro Diagnostic Consulting
Registration of IVD medical devices
Services
Medical devices registration for distribution in Russia and the EEU countries
Providing the IVD medical devices registration in accordance with the Russian Federation’s national rules and the EEU countries’ rules (Armenia, Belarus, Kazakhstan, Kyrgyzstan and Russia).
Technical tests
Technical tests’ preparation, control and results analysis:
- test lab selection
- designing a testing program
- technical writing of necessary documents
Toxicological studies
Toxicological studies preparation for individual cases (e.g. swabs for collecting samples)
Clinical trials organization
Clinical trials preparation, control and results analysis:
- clinical site selection
- clinical study program design
- obtained results analysis and documents preparation
Technical documents review & dossier creation
Technical documentation review for compliance with regulatory requirements
About
IVD Consulting LLC is a consulting company focused on the in-vitro diagnostic medical devices regulation.
Our mission is to improve healthcare with helping medical devices manufacturers to access the market of the Russian Federation and the EEU countries.
Our team
— experts with specialized technical, pharmaceutical and medical education, experience at state laboratories and medical institutions, and competence in IVD medical devices testing and examination.
Thanks to the quality of our work and adherence to deadlines, we have built long-term and trusting relationships with the world’s leading brands of IVD medical devices, such as: Abbott Laboratories, Roche Diagnostics and others.
We find optimal solution to the IVD medical devices registration cases
of any complexity. Registration of IVD medical devices minimizing distribution risks in case
of further state MD oversight.
Availability of many successfully completed projects gives us the
opportunity to build long-term partnerships for mutual benefit.
We constantly monitor legislative changes and deepen our expertise in the field.