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Need state registration of medical devices?
We will save your time and money, as well as overcome all obstacles for you.
Registration of medical devices is a prerequisite for their use and sale on the territory of the Russian Federation. Our company performs a wide range of tasks in the field of registration and certification of medical devices, and provides services for obtaining a registration certificate for a medical device, both in Russia and within the framework of the Eurasian Economic Union (EAEU).
We are ready to take on the project today
and come to a positive result
as soon as possible!
What will we do for you?
Registration of medical devices
1
Разработаем/доработаем нормативную, техническую и эксплуатационную документацию.
Профессионально соберем регистрационное досьe.
2
Поможем осуществить ввоз образцов медицинских изделий для зарубежных производителей.
3
Проведём для вас все необходимые испытания:
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Технические;
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Токсикологические;
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Клинические;
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Метрологические.
4
Будем сопровождать досье в Росздравнадзоре на протяжении всего периода
Amendment of registration documentation
For already registered medical devices, we will update and amend the registration documentation. We will receive a declaration of conformity as soon as possible.
What can we register for you?
Medical products of domestic and foreign production, for example:
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Medical products for cosmetology and plastic surgery (fillers, threads, implants, etc.);
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Dressings and sutures;
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Dental materials;
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Medical masks;
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Devices, apparatuses, devices, devices, equipment and software used for medical purposes;
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Medical supplies
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and much more that is used in medical practice.
Why choose us?
We are ready to solve non-standard tasks.
Do not lose sight of a single detail
Our experience has allowed us to build a sustainable understanding of how to build a process effectively
We carry out registration according to the plan drawn up as soon as possible
We are aware of all ongoing and future changes.
We work for the result
We are always online and ready to help you.
Product testing is carried out only in accredited testing laboratories with state accreditation for technical competence and independence, which are selected in accordance with the specifics of the medical device. Accreditation testing laboratories Federal Accreditation Service (Rosaccreditation).
We trust such organizations as: Biolife Quality Control Center LLC (RA.RU.21TSKO1), ANO Institute of Biomedical Research and Technology (RA.RU.21IM47), ANO Center for Quality, Efficiency and Safety of Medical Devices "(RA.RU.21MD11).
We will be happy to help you with your questions. You can consult with us for free!