Testing facility
Attention is drawn to the fact that the Electrontest Group has medical product testing centers accredited for technical and toxicological testing of medical products. The Group consists of:
- Electrontest LLC IL TSB is accredited by the Federal Service for Accreditation (Rosakkreditation) and the Federal Service for Surveillance in Healthcare (Roszdravnadzor) for technical testing of medical products, including In Vitro products. The quality policy adopted in the laboratory and the current quality management system (Quality Management System and Quality Policy), developed in accordance with the requirements of GOST ISO/IEC 17025-2019, ensure a high level of technical testing and contributes to the development of both the material and technical resources of the laboratory and improvement of the educational background of employees. Electrontest LLC IL TSB is also accredited with the International Laboratory Accreditation Organization (ILAC), which allows to accept test reports for the purposes of registration of the European CE certificate.
- ElectrontestBio LLC is a testing laboratory primarily engaged in biosafety testing of medical products and drugs. ElectrontestBio LLC is a part of Electrontest Group. It increases the capabilities of conformity assessment of medical products by means of complex technical testing in the Electrontest LLC IL TSB and toxicological testing in the testing laboratory of ElectrontestBio LLC with an accreditation certificate RA.RU.21OM13 for testing medical products and drugs to assess their biological safety. It is licensed by the Federal Service for Surveillance on Consumer Rights Protection and Human Wellbeing (Rospotrebnadzor) under License No. 77.01.13.001.Л.000083.11.21 for work with microorganisms of group III and IV pathogenicity.
- Clinical and diagnostic laboratory of Electrontest LLC, which has a medical license for medical research and is also accredited by the Federal Service for Surveillance in Healthcare (Roszdravnadzor) for conducting clinical trials of In Vitro medical products if registered in the Russian Federation and for conducting clinical and laboratory research if registered in the EAEU.
Organization of toxicological studies of medical products
Our company renders service on support of toxicological studies of medical product in testing laboratories of the National Center for Expertise of Drugs and Medical Products of the Republic of Kazakhstan, as well as in the testing laboratory of ElectrontestBio LLC within the Electrontest Group with a view to assess the biological safety characteristics of medical product, as well as the requirements of regulatory documentation of the Republic of Kazakhstan and EAEU.
Organization of electromagnetic compatibility (EMC) testing of medical products
Our company provides a service to support EMC testing of medical products in a testing laboratory with a view to assess the compliance of a medical product with the requirements of technical documentation and state standards in relation to electromagnetic compatibility of products
Organization of medical product testing
Our company organizes all necessary testing/research, as well as provides full support in the process of coordinating the scope of testing/research and the program thereof. We supervise the entire process and check the results for compliance with the requirements of regulatory documents. Furthermore, we coordinate the client in the event of any logistical issues, including assisting in organizing the importation and return of samples, if necessary.
Our company organizes all necessary testing/research, as well as provides full support in the process of coordinating the scope of testing/research and the program thereof. We supervise the entire process and check the results for compliance with the requirements of regulatory documents. Furthermore, we coordinate the client in the event of any logistical issues, including assisting in organizing the importation and return of samples, if necessary.
Our team has many years of experience in developing and updating technical and operational documentation for a wide range of medical devices, including diagnostic equipment, surgical instruments and implantable devices. We work closely with our clients to understand their specific needs and offer customized solutions to meet them. Our task is to develop or correct the highest quality document in accordance with the requirements of the National regulatory authorities of the EAEU Member States and the decisions of the EEC, which complies with all applicable regulatory requirements.
Our company Electrontest LLP provides full customer support in the organization and support of technical testing, toxicological studies, testing for electromagnetic compatibility, as well as clinical trials of medical products. We supervise the entire testing process and check the obtained results for compliance with the requirements of regulatory documents
Organization of technical testing of medical products
Organization of clinical trials of medical products
Electrontest renders service on support of technical testing of a medical product in testing laboratories of the National Center for Expertise of Drugs and Medical Products of the Republic of Kazakhstan, as well as in the testing center of the Electrontest Group in the Russian Federation with a view to assess compliance of technical and operational characteristics of a medical product with the requirements of regulatory documentation of the Republic of Kazakhstan and other EAEU member states, as well as technical and operational documentation.
Our company provides services on support of clinical trials of medical products and clinical-laboratory tests of medical products in vitro in accredited clinical facilities in accordance with the requirements of regulatory documentation of the Republic of Kazakhstan and EAEU.
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We will contact you
Astana, st. Anet baba, 9/3
+7 (776) 326 2500
+7 (702) 999 1964
+7 (701) 419 2225
+7 (702) 999 1964
+7 (701) 419 2225
Our work is based on a deep knowledge of regulatory documents, an understanding of the physics of processes in medical devices, the high qualification of our experts and, most importantly, on our own test base.
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Contacts
For request:
electrontest.kz@gmail.com
electrontest.kz@gmail.com
