Quality control

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

Researching and forecasting demand for medical products both at the domestic and foreign markets
Consumer demand analysis and systematic improvement of products
Performing work and providing services that fully meet the reasonable requirements and expectations of each consumer
Developing the company towards the digital transformation
Development of a new direction of remote monitoring and telemedicine
Implementation of the company's development programme and work to expand the product range in line with it
Participation in the implementation of the Health Development State Programme of the Russian Federation and programmes to combat COVID-19

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.