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We provide comprehensive medical device testing services in accordance with manufacturing control regulations.

  • Successful completion of toxicological testing ensures compliance with safety and quality regulations, which increases market access;
  • Investing in toxicological testing prevents serious costs and risks in the future;
  • This solution will help you save time and money, as well as get an optimal commercial offer for toxicological testing
Get a quote

*If apply today till 1 pm

Our manager is now available for consultation

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.

While the cost of toxicological testing may initially appear as a concern, it is a crucial investment that ensures compliance with regulatory requirements and safeguards the safety and quality of medical devices. By completing these tests successfully, manufacturers gain access to broader markets and mitigate potential legal and reputational risks associated with releasing substandard products

Investing in toxicological testing initially increases a company's costs. However, these costs allow to avoid much more significant future expenses associated with product recalls, legal action and loss of reputation if poor quality products are released to the market.

We offer toxicological testing as part of quality assurance – these are simplified toxicological testing for selected parameters for each product. This will give you the opportunity to check the supplier, batch, new materials and assess the prospects of full medical device testing for registration purposes. This solution will help you save time, money and, in case of successful completion of preliminary testing as part of quality assurance, get an optimal quote for conducting full toxicological testing of a medical device for the purposes of its registration.

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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