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Quality control

Tatiana Beh
Tatiana Beh
Quality engineer
Dear visitors,

Whenever you have comments on the quality of our medical devices, service, or any proposals and suggestions, feel free to contact us by email

qm@monitor-ltd.ru or by phone at +7 (863) 243-63-77, ext. 25.

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.

Our misson

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.

Quality Policy

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.

Our goals for monitoring strategic shifts in market needs

Internal changes goals

  • Complete the construction of the new office building in accordance with the approved design project
  • Commission the new office building
  • Provide resources for the new office
  • Conduct minor repairs of the production premises, Development and Service Departments
  • To ensure the continuity of company operations during the move to the new office building and the reallocation of Production, Development and Service Departments' workplaces
  • Hiring qualified professionals
  • Arrangement of new warehouse facilities
  • Professional development of specialists, staff training in development, design, and production management
  • Continuous improvement of customer service by the company's Service Department, as well as through authorisation of service centres and training of specialists in the regions
  • Provision of resources for the main development areas of the company

Goals for taking account of quality management system requirements

  • Compliance with applicable regulatory requirements in the field of medical devices
  • Timely update of external regulatory documentation for medical devices — transition to MDR 2017/745
  • Effective and efficient operation of the quality management system that complies with the requirements of ISO 13485:2016, Council Directive 93/42/EEC and MDR 2017/745
  • Constant improvement of the quality management system
  • Establishment of mutually beneficial long-term relationships with suppliers who have proven to be reliable in providing products and services that meet established quality requirements, including outsourcing of production processes

The senior management of Monitor Ltd assumes responsibility for:

  • Implementation of the quality policy and objectives
  • Communicating the quality policy to every employee
  • Timely updates of the quality policy
  • Systematic analysis of the effectiveness, efficiency and suitability of the QMS
  • Compliance with legislation, customer requirements and internal company documentation
  • Provision of the necessary resources to achieve the quality objectives

We intend to maintain our leading position among Russian manufacturers and make our products capable of competing in both domestic and foreign markets.