Medalis LLC is a member of Electrontest Group that has been in
business for over ten years and has proven itself as a reliable
partner at the Russian medical device market. Over the years, the
company has successfully marketed over 600 medical devices, ranging
from ordinary medical consumables to major medical equipment.
The Group comprises the following companies:
- Testing Center of Electrontest LLC
- Resultat Audit LLC (registration audit)
-
Center of Technical Safety of Materials, Equipment and Complex
Systems, LLC (CTB MOS LLC) (manufacturing)
- Maxmedtekh LLC (trade)
BACK
The technical device testing laboratory at Electrontest LLC
(Electrontest TDTL) was founded in 2007 under the auspices of the
Moscow Aviation Institute (National Research University). In 2010,
the laboratory was converted into an independent testing center with
continuously evolving testing facilities.
Electrontest TDTL has obtained accreditation for technical tests of
medical devices, including in vitro products, from the Federal
Accreditation Service (Rosakkreditatsiya) and the Federal Service
for Surveillance in Healthcare (Roszdravnadzor). The laboratory’s
Quality Policy and Quality Management System (QMS and Quality
Policy), developed in accordance with GOST ISO/IEC 17025-2019
standard, ensure that technical tests follow strict standards of
quality, independence and impartiality; they also contribute to the
development of both the laboratory’s physical infrastructure and the
improvement of its staff’s proficiency, skills and special knowledge
in the area of testing of medical devices and general-purpose
technical equipment.
LLC "ElectrontestBio" is a testing laboratory, the main activity of which is the testing of medical devices
and medicines for biological safety.
LLC "ElectrontestBio" is part of the Electrontest group of companies and increases the possibilities of
conformity assessment of medical devices through comprehensive technical tests in the IL TSB LLC
"Electrontest" and toxicological tests in the testing laboratory of LLC "ElectrontestBio".
IL LLC "ElectrontestBio" is accredited by Rosaccreditation. Certificate of accreditation RA.RU.21 OM 13
for testing medical devices and medicines to assess their biological safety.
"ElectrontestBio" has a license of Rospotrebnadzor 77.01.13.001.L.000083.11.21 for working with
microorganisms of group III and IV pathogenicity.
Electrontest LLC also has a Clinical Diagnostic Laboratory licensed
for medical tests and accredited by Roszdravnadzor to conduct in
vitro clinical trials of medical devices for their registration in
the Russian Federation and also to conduct clinical and laboratory
tests for the EAEU registration.
Electrontest TDTL is accredited by the International Laboratory
Accreditation Cooperation (ILAC) and can accept test reports for the
European CE certification.
BACK
All member companies of Electrontest Group employ highly skilled
professionals with an extensive experience in medical device testing
and registration support in the Russian Federation. All our
employees have university degrees from the leading Russian
universities, such as the Moscow Aviation Institute (Biotechnology
specialists), Bauman Moscow State Technical University
(Biotechnology Faculty graduates), Mendeleev University of Chemical
Technology of Russia, Moscow Medical Academy, Moscow Engineering
Physics Institute, and others.
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