The circulation of only registered medical devices is permitted within Russia, as required by Roszdravnadzor. The circulation of medical devices includes various testings, their state registration, manufacturing, import into or export from the Russian Federation, storage, acceptance of conformity, operation, including maintenance stipulated by the manufacturer’s documentation, and disposal. For the purposes of state registration of medical devices, as required by the executive body (Roszdravnadzor), the conformity is assessed in the form of clinical, technical and other types of tests.
FCRC offers a wide range of services for medical device testing. Our specialists are ready to organize the entire range of trials in accordance with the client’s requirements and wishes.
Types of Medical Device Tests
We organize the following trials:
- Technical
- Clinical
- Toxicological
- For type approval of measuring instruments.
Roszdravnadzor considers the results of trials conducted in laboratories accredited in the national accreditation system in accordance with the Federal Law No. 412-FZ dd. December 28, 2013. Therefore, all laboratories we cooperate with are state registered in the national accreditation system. We regularly work with many testing centers, which allows us to select the best conditions regarding the timing and cost of medical device testing for our customers.
Our Services
Work with us is organized according to a certain algorithm, which includes:
- Selection of an accredited institution for your task.
- Preparation of documents required for medical device testing.
- Organization of testings. Coordination of the number of sample medical devices.
- Assistance in preparation of the documents required for sample import for the purpose of subsequent registration of medical supplies and test organization.
- Check of the expert opinion and, if necessary, introduction of amendments into the documentation.
The procedure, cost and timing of trials are subject to the following factors: whether the documentation is ready, what specific types of procedures need to be performed for your medical device, required number of samples, etc.
Our experts are highly qualified. We are ready to answer all your questions and help you choose the most optimal services for your product. Contact us, and we will diagnose your medical devices in the shortest possible time and according to your requirements.
Advantages of Cooperation with Us
You can also appreciate the benefits of working with us:
- We have certain specialists on our staff who organize tests.
- We have a pool of accredited organizations for all possible options of trials.
- We set realistic deadlines for work and guarantee strict adherence to them.
- We provide transparent pricing.
It is easy to start cooperation—send your application to info@fcrc.consulting or call us at +7 (495) 374-00-19.