The developer of Cardiovisor and the project Kardi.Ru is the company "Medical Computer Systems". The company specialises on manufacture of high-tech medical devices for Cardiology from 1993 year. Technical decisions of the company are widely used in Russia and abroad.
The company Medical Computer Systems possesses the certificated management system quality of production according to the international standards.
DIN EN ISO 9001:2000 (certification area - design, development and sale of medical devices),
DIN EN ISO 13485:2003 (certification area – design, development and distribution of active medical devices: electrocardiographs, EEG, polygraphs),
and the European Directives 93/42/EEC about medical devices.
The company can guarantee compliance with these standards in the design and production, as well as to produce medical equipment with CE marking.
All certificates are issued and maintained on the basis of annual audits conducted by EUROCAT. EUROCAT "Institute for Certification and Testing GmbH" (Frankfurt, Germany) is an institute for the certification testing of medical devices and software, as well as the quality management system certification in the field of health and production of medical devices. EUROCAT is recognized by the notified body for medical devices in Europe with license plate CE 0535.
ISO 9001:2001 – it is recognized the most complete and universal standard of quality businesses, regardless of their professional conversion and forms of ownership.
ISO 9001:2001, based on the process approach, allows to demonstrate stable high quality of products or services to the consumer.
ISO 13485:2003 – is a standard management of companies quality system, that implement the design, development, production, assembly and servicing of medical devices. Besides demands ISO 9001:2001a number of specific conditions are include in the standard: risk management; necessity of documentary procedure of designing and development of medical devices; additional demands to purity of production and pollution control; special requirements for sterile medical devices; demands to hygiene of staff, the equipment and locations; and additional requirements for the feedback system in order to obtain early warning of problems in the field of quality, etc.
CE marking for medical product can be applied only after all conditions of European law – directive 93/42/EEC, that must be confirmed by the relevant certificate. Transcription of CE from the French "Conformité Européene" (CE) means "European Conformity" and allows for labeled products without restrictions in the European Community. Medical Computer Systems puts CE label on computer system HeartVUE – it is analogue of system CARDIOVISOR for the European and American customers.
The license for the production of medical equipment, which is issued by the Federal Service on Supervision of Public Health and Social Development of the Russian Federation.
The registration certificate on the computer system for heart screening "Cardiovisor" and on Kardi.Ru system
Declaration of conformance on the computer system for heart screening "Cardiovisor"
The technology of dispersing mapping is protected by patents of Germany ( DE 19801240, DE 19952645, Soula A.S. etc.) and USA (US 7519416, Sula A.S. etc.).
In the Russian Federation by patents are protected: system for remote patient monitoring, technology transfer examination from the patient on the server and from patient to doctor, software for automatic generation of conclusions and trademark Cardiovisor.