MONITOR LTD is a Russian research and production company which has developed and certified its own quality management system according to international standards (ISO 13485). Besides, we have the European CE certificate for all our products.
To improve the quality of the medical equipment, competitiveness and efficiency of work, in 2005 our company implemented an international quality management system which was certified for compliance with ISO 9001 standard. Over the years, the company's activities have been constantly analyzed for efficiency and improvement opportunities.
In 2007, the BSI International Certification Body issued a certificate confirming the compliance of the company's quality management system with the requirements of ISO 13485 standard (Medical Devices — Quality Management Systems — Requirements for Regulatory Purposes). The effectiveness and efficiency of our work is supported by annual audits.
We aim to develop and implement into practice competitive methods and technical means for disease diagnosis and health monitoring that could provide the most effective treatments and preservation of health for as many people around the world as possible.
The company has defined the basis of its quality activities as a steadily growing quality of the medical devices, which is achieved by using advances in science, equipment and technology that comply with the requirements of ISO 13485:2016 international standard, EU Council Directive 93/42/EEC, Medical Devices Regulation (MDR) 2017/745 and Russian legislation in the field of medical devices.
The high quality of the medical devices produced by Monitor Ltd is ensured by taking into account all strategic shifts associated with changes in market needs, anticipated internal changes, and changes in the requirements for the quality management system.
We intend to maintain our leading position among Russian manufacturers and make our products capable of competing in both domestic and foreign markets.