Manufacture and quality system

Principal attention in the work of the enterprise is given to quality and safety of manufactured products which are provided by the presence of certified and constantly improved quality management system, modern technologies and equipment, highly qualified staff.

The products of the enterprise of 1, 2 and 3 class of potential risk of use according to the classification of Directive 93/42 are manufactured in controlled conditions of clean rooms at modern efficient equipment of the leading European manufacturers: these are injection molding machines and extrusion machines, cytobrush automatic machines, packing, coiling, filling machines, etc. During the process of manufacture are used raw materials and semi-processed products of verified and reliable suppliers who have certified quality management systems. All materials undergo thorough incoming inspection according to quality and safety indices. Quality of manufactured products is provided by adherence to manufacturing, packing and keeping techniques. Validated process of finish irradiation, gas or plasma sterilization is carried out at modern certified equipment.

Management of products quality is based on constant orientation at consumer with compulsory observation of safety requirements for products. Employees of the enterprise carry out constant monitoring of manufactured products, gather suggestions for its improvement. This information constitutes the basis for the process of projecting and development of new products, improvement of serially manufactured products. Development and perfection of products is based on the analysis of world trends of medical products market development, own and carried out together with the leading clinics scientific research works, marketing and patent research. New products are created using automatic projecting systems, undergo testing for safety and clinical evaluation in the leading clinical centers of Belarus and Russia, receive patent protection. From 2006 the enterprise has implemented and certified quality management system which conforms to the requirements of ISO 9001. At the present moment are carried out works on the implementation of quality management system according to ISO 13485 and receiving CE mark under the surveillance of EU notified body.

At the enterprise work highly professional employees, they are involved in the work on implementation and perfection of quality management system and improvement of products quality. Employees of the enterprise constantly improve their qualification owing to training and certification both at the enterprise and foreign courses, seminars and symposiums. The staff of the enterprise includes two Candidates of Technical Science, Candidate of Medical Science, highly professional engineers, designers, technologists, doctors and specialists. At the enterprise has been created and is functioning the system of material reward for the accomplishments in the field of quality. All working places undergo certification according to safe working conditions, is carried out monitoring of ecological state of environment and are carried out environmental protection measures.

History 

CJSC «Medical enterprise Simurg» was founded in 1991.

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