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Simera combines expert skills and high-accuracy work with exceptional communication and efficiency
SIMERA: MORE THAN JUST A LAB – A NEW GENERATION OF EXCELLENCE

Simera combines expert skills and high-accuracy work with exceptional communication and efficiency

Simera combines expert skills and high-accuracy work with exceptional communication and efficiency

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

Аккредитованы
на международный знак ILAC

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

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

Optional services

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.