Clinical trials or clinical research for medical devices
  • Центр испытаний и регистрации медицинских изделий. ООО «ЦИРМИ»
115487, город Москва

ул. Нагатинская, д. 16

+7 (495) 199-72-57

+7 (968) 480-70-88

Clinical trials or clinical research for medical devices

Регистрация медицинских изделий в Росздравнадзоре

Clinical trials of medical devices

Clinical trials (or clinical research) of medical devices is a procedure for confirming the quality and safety of medical devices in accordance with clinical indicators and standards approved and agreed with the testing laboratory.

Clinical trials are carried out by medical organizations approved by the Federal Service for Surveillance in Healthcare (Roszdravnadzor) and the Federal Service for Accreditation (Rusaccreditation).

There are two types of clinical trials of medical devices: in the form of analogy with other medical devices and in the form of actual trials to assess their safety and effectiveness, including with human participation.

In the latter version, tests are carried out in relation to a new type of medical device, the use of new complex or unique methods of prevention, diagnosis, treatment of diseases, as well as new complex medical technologies; and are also carried out if the efficacy and safety of the medical device was not confirmed during the first form of research.

What is needed for a successful clinical trials:

  • A sample of the medical device;
  • Permission to conduct clinical trials issued by Roszdravnadzor (we will help with obtaining);
  • Test reports from other testing laboratories (if any);
  • Conclusions of toxicological studies of a medical device (we will help with obtaining);
  • Technical documentation for a medical device (we will help with development);
  • User manual for a medical device (we will help with development);
  • Photos of the medical device.

Experts who are ready to solve your problem:

  • Project manager for work with clients and his assistant,
  • Specialist in the development of documentation and his assistant,
  • Translators,
  • Testing expert (technical, toxicological and clinical trials),
  • Courier.

Here you can see the full price list for our services.

Since 2011, Goszdravnadzor has been professionally engaged in the provision of services for the registration of permits. During our activity, we managed to study this direction down to the smallest nuances. Today we can confidently declare that we are one of the leaders in the development and execution of permits.

Benefits of cooperation with Goszdravnadzor:

Command with a common goal

The Goszdravnadzor company as an organism united by a common goal — to do the work so that the client is satisfied, turned to us again, and advised colleagues. An optimally selected staff of employees successfully resolves any issues during the performance of work, moreover, it does it without involving other performers. The client will not “lose” his project manager, as our staff turnover is minimal.

In words, in a contract and in work

The obvious superiority of Goszdravnadzor over competitors is transparent and honest interaction with the customer. After receipt of the offer, you can be sure that the price and terms of the provision of services in the final there. During the entire period of work, there has not yet been a case when the cost of the work agreed with the customer was overstated or changed. If mistakes are made on our part, we will compensate the costs of correcting them at our own expense. The client makes payment in stages — upon completion of the work.

Guaranteed successful completion of the project

Until the conclusion of the contract, specialists with specialized education conduct a thorough analysis of the available documentation for products or equipment. In the absence of the necessary information, we will certainly notify the customer about this. In this way, we reduce the risk of a negative result and also reduce the turnaround time.

Experience. Knowledge. Authority.

Since 2011, the Goszdravnadzor company has been carrying out projects of varying complexity and focus. We have worked with both simple (one-component) medical devices with a low hazard class and high-tech medical equipment. Extensive knowledge of experts and well-established relations with government agencies allow you to work faster, draw up documentation the first time, and carry out tests without a headache for the customer.