Toxicological testing of 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

Toxicological testing of medical devices

Регистрация медицинских изделий в Росздравнадзоре

Toxicological testing of medical devices

Toxicological testing of medical devices is a procedure for confirming the quality and safety of medical devices in accordance with the toxicological indicators and standards approved and agreed with the testing laboratory.

For all medical devices that come into contact with the human body during their use, toxicological tests are prescribed.

Toxicology is based on the determination of the level of impact on the human body and includes the verification of physical and chemical, sanitary and chemical, biological indicators, including biological indicators in vitro and in vivo.

Medical devices intended for contact with the human body:

  • Medical devices in contact with the human surface (skin);
  • Medical devices temporarily introduced into the human body;
  • Medical devices intended for implantation into the human body.

On average, toxicological tests are carried out no longer than twenty working days, however, if additional tests are required, this period can be increased with the consent of the customer.

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.