We are happy to announce successful completion on the 6th of April 2006 of assessment of the Quality Management System of ELECTROPULSE company to the requirements of ISO 9001:2000 - Quality Management System Certification, ISO 13485:2003 Medical Device Certification and Directive 93/42/EEC Annex II (excluding Section 4).
The level of sophistication and complexity of our medical equipment and possibility of its influence on health of the patients and medical personnel determines high requirements to quality of production as to the most important criterion of the company work. The basic purpose of ELECTROPULSE is comprehensive satisfaction of consumer requirements - both patients who are interested in the most qualitative diagnostics and treatment, and medical personnel for which safety and convenience of use and simplicity of equipment service maintenance is important. In this connection in the field of quality ELECTROPULSE company solves the following tasks: Maintenance of high technological level of the produced equipment, allowing to receive maximum qualitative result of diagnostics and to achieve the maximal safety of patients and the medical personnel.
Maintenance and improvement of operation convenience of the produced equipment.
The organization and perfection of maintenance service.
Maintenance of stability and constant increase of a degree of quality of the equipment and services. The quality policy stated above expresses a principled position of ELECTROPULSE company management. To achieve this objective our company the Quality management system was systematically developed, implemented and improved according to requirements of international standards ISO 9001:2000, ISO 13485:2003 and Directive 93/42/ÅÅÑ. This system covers all processes of company functioning including design, development, purchases, manufacture, tests, storage, installation and service of medical equipment. Certification of the Quality management system and confirmation of ELECTROPULSE products conformity to the European requirements have been carried out by SGS company - the global leader in the field of inspection services, verification, testing and certification, which has been rendering services in the Russian market for 25 years. The medical equipment of ELECTROPULSE company: "ELKART II" system for electrophysiologic diagnosis and therapy of heart, "S-350 RF" electrosurgical generator, "ALLIGATOR" bipolar vessel sealing system, "ARGON PLUS" argon gas supply unit have received the right to be ÑÅ marked as a confirmation of conformity to requirements of the Directive of Council of the European community 93/42/ÅÅÑ on the medical devices. These products became one of the first in Russia, received ÑÅ mark in such high class of potential risk, as IIb. | 
