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SIMERA IS MORE THAN JUST A LABORATORY

We will perform toxicological testing of a wide range of medical devices according to national regulations and within the framework of the eeu

We will perform toxicological testing of a wide range of medical devices according to national regulations and within the framework of the eeu
  • We conduct sanitary-chemical and biological testing;

  • We organise full-cycle testing for the registration of medical devices;

  • We guide the registration process from the launch of testing to the receipt of the RC; 

  • We organize the samples delivery by our own logistics department from any location in Russia and around the world;

  • The term starting from the application till the quote and the launch of the testing is minimum.

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.

We will perform toxicological testing of a wide range of medical devices according to national regulations and within the framework of the eeu
The principal business activity of testing laboratory STK LLC

Toxicological testing of medical devices for registration purposes

For the purposes of state registration of medical devices according to the procedures established by the Federal Service for Surveillance in Healthcare, conformity assessment in the form of technical tests, toxicological testing, and clinical tests is carried out.
 

Products tested

Internal and External
Prosthetic Devices

Surgical
Dressings

Dental
Supplies

Ophthalmic
Products

Medical
Instruments

Medical
Equipment

Blood-Contacting
Medical Devices

Medical
Furniture

Medical
Wear

Full list of products tested:
On the FSA of Russia website
 
Areas of accreditation

Download ~5mb

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).
Our commitment to exceptional testing accuracy is

Complemented by a management system built on AGILE principles, ensuring a smooth and comfortable experience for you when working with our laboratory

Our approach ensures a fast document flow, no delays at all stages of work and quick feedback at any stage.

Qualified personnel

We strictly follow the state requirements

Availability of a vivarium and in vivo testing

We make a quote within 1 working day at the most

A personal manager supervises your project 24/7

 
  • You will receive all information about the work progress in any way you prefer:

    Whatsapp Telegram Е-mail Phone
  • Testing periods are state regulated and range from 28 days to 45 calendar days. While we can't expedite the process, we're committed to streamlining the initial testing phase and issuing documents quickly upon completion
Our service package includes comprehensive expert consultations and ongoing project support. Our meticulous analysis and evaluation of your documentation minimize the risk of errors in the registration dossier and ensure a smooth regulatory review, giving you confidence in a successful outcome.
Andrey Antonov Write to
CEO Simera-TK LLC

There is no need to go to other laboratories or to look for specialists in medical device registration. with us, you get all services in a one-stop approach:

  • We carry out toxicological testing;
  • We have an extensive scope of accreditation: we carry out sanitary-chemical, physicochemical and biological tests;
  • We cover the full list of required standards for conducting 99% of medical devices types

We provide both testing services and comprehensive services to support the registration process of medical devices

The testing laboratory of Simera LLC

Is fully equipped to conduct a comprehensive range of tests

All units of the laboratory are located in specialised areas providing the necessary conditions for their functioning

All facilities are equipped with an autonomous system of exhaust and supply ventilation, operating in automatic mode to ensure a preset ventilation balance in clean and dirty rooms.

  • Lab scales ВЛ-224В
  • Unico spectrophotometr model 2804
  • Medical testing hardware and software kit on the chromatograph Chromatech-Crystal 5000_ v.2 platform
  • Ohaus AB33EC liquid analyser complete with electrode
  • UNIPLAN AIFR-01 enzyme immunoassay reaction analyser
  • Image (toxicity) analyser AT-05
  • Atomic absorption spectrometer A-2
  • Liquid chromatograph Shimadzu LC-20 prominence
  • FiveEasyF20 Mettler-Toledo pH meter
  • Laboratory centrifuge LMC-4200R
  • Electric dry-air thermostat TS-1/80 SPU
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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