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, the expert department of the CIRMI company has been professionally engaged in the provision of services for the preparation of permits. During our activity, we managed to study this direction to the smallest nuances. And today we confidently declare that we are one of the leaders in the design and development of permits for medical devices!
Working without delays
We understand the value of our clients’ time better than others and never delay projects!
We know the law very well
We know how to properly communicate with expert organizations and Roszdravnadzor.
Work with us reliably
During the work of the company, not a single lawsuit was filed in court. Our pride!
Benefits of cooperation with CIRMI:
A team with a common goal
The CIRMI company is an organism united by a common goal — to do the job so that the client is satisfied, contacted us again, and advised colleagues and friends. An optimally selected staff successfully solves any tasks in the implementation of projects, moreover, it does this without the involvement of other performers. Our client will never «lose» their project manager as we have no staff turnover.
In words, in contract and in work
The obvious superiority of TsIRMI over its competitors is transparent and honest interaction with the customer. After receiving a commercial offer, you can be sure that the prices and terms for the provision of services in it are final. For all the time of work, there has not yet been a case when the cost of work agreed with the customer has been changed. If errors are made on our part, we will compensate for the costs of their correction at our own expense. The client makes payment in stages — upon completion of the work.
Project Success Guarantee
By the time the contract is concluded, specialists with specialized education conduct a thorough analysis of the available documentation for the medical device. In the absence of the necessary information, we will definitely notify the customer about this. In this way, we reduce the risk of a negative result and reduce the time for completing the work.
Experience, knowledge and prestige.
Since 2011, experts from the CIRMI company have been implementing projects of varying complexity and focus. We have worked with both simple (single-component) medical devices with a low hazard class and high-tech medical equipment. Extensive knowledge of experts and established relationships with government agencies allow us to work faster, carry out tests the first time, and develop documentation without a headache for the customer.
- Главная
- Registration in RZN
- CLINICAL TRIALS OF MEDDEVICES
