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We carry out a range of tests for conformity assessment of medical devices on a one-stop approach

  • We assess compliance of medical devices through toxicological testing, technical and clinical testing.
  • We offer a set of tests on the principle of one-stop approach, combining toxicological testing and technical tests to save time and money.
  • We are responsible logistical issues related to sample delivery and provide a full package of documents on test results.
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*If apply today till 1 pm

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It will take ~2 minutes to fill in the application form. We will call you back to clarify the details and you will receive the cost estimate today.

According to the Order of the Ministry of Health of Russian Federation dated August 30, 2021 no. 885n “On approval of the procedure for a conformity assessment of medical devices in the form of technical tests, toxicological testing, and clinical testing for the purpose of the marketing authorization of medical devices” conformity assessment of medical devices is carried out in the form of:

  • toxicological testing
  • technical tests
  • clinical tests

Testing Laboratory SIMERA carries out a complex of tests on a one-stop approach. We simultaneously run toxicological testing and technical tests, saving you from unnecessary financial and time costs for coordinating the work of different laboratories

Samples are delivered to our office located in the centre of Moscow. We are responsible for all logistical issues of sample delivery to laboratories and provide you with a set of documents on the results of all tests types in our office.

Technical tests - are tests to determine whether the characteristics (properties) of a medical device meet the requirements of regulatory, technical, operational documentation of the manufacturer and to decide whether to conduct clinical tests.

We conduct all types of technical tests:

  • General technical tests (dimensions, weight, mechanical characteristics of the medical device material such as density, strength, disinfection resistance, etc.);
  • Climatic and mechanical impacts (temperature and humidity exposure of the medical device; vibration and shock loads, etc.);
  • Functional testing (oxygen concentration in the inspiratory flow; air flow rate through the inlet of the device; aspirator suction velocity; oxygen saturation monitor measurement limit, test according to standarts of GOST R ISO 80369 ((liquid leakage, leakage due to pressure drop, air leakage under the influence of low pressure), etc.);
  • Electrical safety tests (tests according to regulations for electrical safety of medical devices in accordance with GOST R IEC 60601-1; electrical safety of monitoring and measurement electrical equipment and laboratory equipment according to GOST IEC 61010-1).
  • Technical tests of medical devices for in-vitro diagnostics (tests of reagents for in vitro diagnostics; analysers for in vitro diagnostics).

After successful toxicological testing and technical trials, there remains the final stage of conducting complex trials - clinical testing. This is a designed and planned systematic testing involving human as a subject to evaluate the safety and efficacy of a medical device.

Clinical testing conducted:

  • in the form of testing (analysis and evaluation of clinical data);
  • in the form of trials, including those involving human, carried out to assess the safety and efficacy of a medical device.

Testing laboratory Simera-TK LLC is a modern testing laboratory for medical devices toxicological testing

The testing laboratory operates on the basis of GOST ISO/IEC 17025-2019 "General requirements for the competence of testing and calibration laboratories", accreditation criteria approved by the order of the Ministry of Economic Development and Trade No. 707 dated October 26, 2020 and internal quality management system documents.

In our work we use modern approaches to communication with partners, new high-precision and technological equipment and strict compliance with state regulations in the field of testing.

Сurrent member of
CCI and MCCI

FSA RF accreditation
RA.RU.21OT23

Current members of
Business Russia organisation

Partners of the laboratory
holding Leon JSC

Partners of the ФГБУ ВНИИМТ
Росздравнадзора

Testing laboratory
Nimaxlab

We work with both domestic and foreign medical device manufacturers worldwide:
  • Over 300 Domestic Manufacturers;
  • Over 75 Companies from Asian countries;
  • Over 30 Companies from Europe;
  • Over 45 Companies from EAEU countries;
  • Over10 Companies from North America;
Simera-TK Testing Laboratory was included in the following registers and lists:
  • Register of Accredited Persons (RAL) of the Federal Accreditation Service (FAS) of the Russian Federation. The number of entry in the RAL is RA.RU.21OT23 FSA.
  • List of organisations authorised to conduct trials (tests) to assess the biological effect of medical devices for the purpose of their registration with the Federal Service for Surveillance in Healthcare of the Russian Federation;
  • Unified Register of Testing Laboratories (TL) of the Eurasian Economic Commission (EEC).
Workflow

We have made communication with the laboratory direct, easy and convenient. The elimination of interaction problems reduces the project delivery time by several times.

We prioritize efficient communication in such a way that you get quick answers to all your questions: both at the beginning of interaction and during tests. We know the importance of minimizing delays at work due to bureaucratic delays and problems in the interaction "laboratory - partner". We aim for your results.
Polina Kamzarakova
Deputy Head of business development
1
First step
  • Contact us by any means:

Result:

We negotiate the contract and start the tests

generally ~ 2-3 days

2
Preparation
  • We arrange the samples import for launching testing, if required;
  • We receive the samples for launching testing;
  • We compile the testing programme and launch the project.

Result:

Samples -> programme -> start testing

generally ~ 1-2 days

3
Testing
  • The laboratory conducts testing
  • You receive a full package of documents on the results of the conducted testing: testing programme, protocol, conclusion on the results of the testing

Result:

Protocols of toxicological testing are attached to the package of documents for the medical device proposed for state registration for full circulation on the territory of the Russian Federation and the Eurasian Economic Union (EAEU).

generally ~ 28-45 days depending on the product

Seamless sample delivery: worldwide expertise
  • We have an in-house logistics department with expertise in delivering medical device samples from anywhere in Russia or the world.
  • Leave your concerns about shipping expensive or bulky equipment behind – we handle the logistics, ensuring your samples arrive safely and efficiently.
Expert translation services
  • If your documentation is in a foreign language, it will need to be translated into Russian. The translation must be accurate and compliant with regulatory requirements.
  • We have a long-standing relationship with Lingvisto, a trusted translation agency, and recommend them to all our partners for their localization needs
We work with a reliable integrated exchange agent
  • We have a proven track record of success, collaborating on over 50 projects with experts in international trade;
  • We offer full exemption from interaction with the Federal Customs Service (FCS);
  • Our agent provides a full suite of services to support your projects, including import/export, logistics, customs clearance, engineering, warehousing, analytical and technological equipment maintenance, and factoring.
8 (495) 649-64-06

Mon-Fri 09 am-6 pm, Fri till 4:30 pm

This email address is being protected from spambots. You need JavaScript enabled to view it.
Andrey Antonov Write to
CEO Simera-TK LLC

We are ready to start the work

Fill in the application form and I will contact you for a consultation
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