PKF SIM-technika Ltd. registered as a company
Company’s History
First sales of products in Russia By resolution of the Commission on Devices and Technical Equipment for Oncology and Medical Radiology Facilities under the Committee for New Medical Equipment of the Ministry of Health of the RF, MEIK, Computerized Electrical Impedance Mammograph for Breast Screening with Visualization of Electrical Conductivity Distribution was registered as medical device and recommended for serial production and clinical application. The mammograph is registered in the State Register of Medical Devices. First export sales of devices (Slovakia, Czech Republic, Malaysia)
ISO 9001 and ISO 13485 certification of the Company’s QMS by a Russian company Russkiy Registr;
startup of works on a new version of the mammograph (MEIK, version 5.0) with application of new mathematical algorithms of image reconstruction.
In accordance with Order No.744 of 01 December 2005 of the Ministry of Public Health and Social Development of the RF, Electrical Impedance Mammography, code A 05.20.001 became a part of standard of medical care for patients with malignant breast tumours.
Registration of MEIK and SIM-Technika trademarks in the Public Register of Trademarks and Service Marks of the Russian Federation
Patent received for utility model of Computerized Electrical Impedance Mammograph; certificate received for the official registration of Software for MEIK, Computerized Electrical Impedance Mammograph software;
sales of the new version of MEIK, version 5.0 launched;
Organization of own manufacturing site, its licensing.
ISO 9001, ISO 13485 and ISO 13485 CMDCAS (Canadian Medical Devices Conformity Assessment System) QMS of the manufacturing site certification completed by DQS Medizinprodukte GmbH, Germany.
Eurasian patent received for the invention of Computerized Electrical Impedance Mammograph. The patent is acknowledged in the RF, Republic of Belarus, Kazakhstan Technical and clinical trials, registration, certification and organization of licensed production of MammoScreen, electrical impedance mammograph in the Republic of Belarus at the manufacturing site of TahatAksi, Additional-Liability Company, Minsk (www.tahat.by ).
Preparation and publication of «Standards for Electrical Impedance Mammography» chapter in the book Imaging of the Breast - Technical Aspects and Clinical Implication, (21) edited by Dr. Laszlo Tabar
Eurasian patent for invention registered and introduced in the national phase in China.
Postclinical trials of MEIK, electrical impedance mammograph held in St. Elizabeth Cancer Institute, Bratislava, Slovak Republic.
Successful recertification audit for 93/42/ЕЕС Directive conformity; a new EC CERTIFICATE received.
Consolidated medical experience of application of MEIK, electrical impedance mammograph, was reported for the first time at the largest international event World Cancer Congress (Canada, Montreal).
SIM-Technika became the member of Yaroslavl Regional Chamber of Commerce and Industry.
Jointly with MMK Formed, LLC (www.fmed.ru) and NPO Medcar, LLC (www.medcar.ru) Operation Guidelines were developed for preparation of MEIK, electrical impedance mammograph, for use by mobile teams. Mobile medical teams started using MEIK, electrical impedance mammographs (diagnostics, screening, occupational health examination, Health Centre, Mobile Policlinic, Women’s Health) made by NPO Medcar, LLC According to Directive of the Government of the RF No.1416 of 27 December 2012 On Approval of Rules of State Registration of Medical Devices and due to expiration of previous Registration Certificate, SIM-Technika successfully underwent full set of technical, toxicological and clinical trials of MEIK, computerized electrical impedance mammograph with software version 5.6, and received a new registration certificate, as well as the License to manufacture and service medical equipment. Jointly with Asian partners, works were launched on the development of a new version of software for MEIK, electrical impedance mammograph, to be used for large-scale screenings. Jointly with partners from MEIK Ltd. (Hong Kong) the cycle of certification trials of the full quality management system for MEIK, electrical impedance mammograph, for compliance with the standards of European Directive 93/42/EEC for medical devices in the British institute of Standards (BSI). New software version put into practice for breast screening. The version is intended to be used in Asia. Jointly with partners from MEIK Mexico S.A. and Instituto Mexicano del Seguro Social (IMSS) large-scale clinical trials for MEIK, electrical impedance mammograph, were held. During the trial, more than 1 000 patients were examined. Final results confirmed high efficacy of MEIK, electrical impedance mammograph (Se 85%, Sp 97%).
As the result, EC Certificate for Full Quality Assurance System (CE2797) was issued.
No X-rays