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We will perform toxicological testing of a medical device timely and at a fixed cost

During testing, we determine:
  • Conformity of the medical device with the requirements of applicable national (international) regulations, regulatory documentation, and the manufacturer's technical and operational documents;
  • Adherence of the documentation to the requirements of applicable national (international) regulations and regulatory documentation for the medical device;
  • Completeness and objectivity of the specifications established by the manufacturer's technical and operational documentation to be assessed during toxicological testing of the medical device;
  • Safety of use of the medical device.
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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.

Toxicological tests are performed only in a testing laboratory accredited in the national accreditation system (SIMERA Testing Laboratory - FSA RF Accreditation (RA.RU.21OT23) in order to assess the safety of a medical device and make a decision on conducting clinical testing.

Toxicological tests are mandatory for the registration of medical devices and (or) accessories to a medical device:

  • contacting the surface of the human body;
  • temporarily introduced into the human body from the outside;
  • implanted into the human body;
  • having indirect contact with the human body.

Documentation to be provided by the applicant for the testing

As an initial step, we ask for your application to test and manufacturer's technical documentation. We will carry out a preliminary assessment of the documentation and assist you in compiling the correct application to avoid potential errors.

Scope of toxicological testing

We perform a full range of testing required for regulatory compliance and quality assurance of medical products.

Toxicological testing programme

Toxicological testing plan and report

You receive:

1. Toxicological Testing Plan for a Medical Device: Our experts will develop a preliminary plan based on relevant regulations. After your approval, we will proceed with testing within one working day of receiving samples at our laboratory.

2. Test Protocol

3. Toxicological Testing Report for a Medical Device: This report will include the testing plan, protocol, and summary of results.

Remarks to toxicological testing reports

We try to minimise the risk of receiving remarks to the documents we issue on the results of toxicological testing.

As an independent, full-service laboratory, we manage the entire testing process without the involvement of intermediaries. We implement the latest technologies of enterprise management, which allow us to:

  • Minimise the risk of potential errors;
  • Maintain seamless internal documentation processes to meet contractual deadlines;
  • Minimise the cost of retesting - there will be no need for re-testing.

We acknowledge that errors may occur, and we are committed to promptly rectifying any mistakes on our part at no additional cost.

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

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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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