We’ll assist you to prepare all the necessary documentation for your registration dossier and will provide support during the registration process with the Authorized Bodies.
We provide assistance with revision to registration certificates and registration dossiers, replacement of registration certificates, duplicate registration certificates.
We are available to give advice on revisions as per the EAEU regulations as listed in Annexes to Decision 46 of the EEC Council.
We shall assist you to prepare technical documentation for the subsequent registration of your medical device.
We shall assist you to prepare operational documentation for the subsequent registration of your medical device.
We shall arrange technical tests, toxicological tests, electromagnetic compatibility (EMC) tests, and clinical trials of medical devices, as well as provide you with the necessary support during the testing process.
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:
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.
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.
Medalis LLC is a part of Electrontest Group that has been in business for over ten years and has proven itself…
The technical device testing laboratory at Electrontest LLC (Electrontest TDTL) was founded in…
All member companies of Electrontest Group hire highly skilled professionals with extensive work experience in testing...