Technical testing of medical devices
Technical testing of medical devices is a procedure for confirming the quality and safety of medical devices in accordance with the technical indicators and standards approved and agreed with the testing laboratory.
There are two formats of technical tests for registration of the registration certificate of Roszdravnadzor: in the form of assessing the quality of medical devices or in the form of real tests in the laboratory.
- The first form is carried out in the relations of products, for the commissioning or installation of which a special permit is required, or for the creation of conditions or the construction of individual capital structures, that is, an analysis is made based on the documentation provided by the manufacturer. If the analysis, assessment of the submitted documentation does not allow us to speak unambiguously about the quality and safety of a medical device, then real tests are carried out in a testing laboratory.
- For all other medical devices, the second option is used — carrying out real tests in the laboratory.
The procedure for conducting technical tests of medical devices is given in the order of the Ministry of Health of the Russian Federation dated January 9, 2014 No. 2n. The link to download the document is here.
Our customers can independently choose for themselves a testing laboratory that carries out technical tests of medical devices, and at the same time, we also offer to use our own testing laboratory, in which the testing time is minimal, and the probability of successful testing is as high as possible.
Here you can see the full price list for our services.
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,
- Testing expert (technical, toxicological and clinical trials),
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.