The products of the enterprise, 1, 2 and 3 classes of potential risk of use according to the classification of Directive 93/42 EEC, are produced in controlled conditions of clean rooms on modern high-performance equipment of leading European manufacturers these are injection molding machines and extruders, cyto-brush machines, packaging, winding, filling machines and other .
In the production of raw materials used and semi-proven and reliable suppliers with certified quality management system. All materials undergo a thorough entrance control in terms of quality and safety. The quality of products is ensured by compliance with the technology of production, packaging and storage.
Validated process of finishing radiation, gas and plasma sterilization is carried out on modern certified equipment.
Product quality management is based on continuous customer orientation with mandatory compliance with product safety requirements. Employees of the company conduct continuous monitoring of products, collect proposals for its improvement. This information is the basis for the process of designing and developing new products, upgrading commercially available. The development and improvement of products is also based on the analysis of global trends in the development of the market for medical products, on our own research projects conducted jointly with leading clinics, and on marketing and patent research.
New products are created using computer-aided design systems, undergo safety testing and clinical evaluation at leading clinical centers in Belarus and Russia, and receive patent protection.
Since 2006, the company has implemented and certified a quality management system that meets the requirements of the international standard ISO 9001. Currently, work is underway to implement a quality management system that meets the requirements of the international standard ISO 13485 and to obtain CE marking under the supervision of a notified EU body.
The company employs highly qualified personnel involved in the implementation and improvement of the quality management system and improving product quality. Employees of the company constantly improve their qualifications, being trained and certified both within the walls of the enterprise and at foreign courses, seminars and symposia. The company employs two candidates of technical sciences, a candidate of medical sciences, highly qualified engineers, designers, technologists, doctors and specialists. The company has established and operates a system of material incentives for achievements in the field of quality. All workplaces are certified for safe working conditions, the environmental condition of the environment is constantly monitored, and measures are taken to protect it.
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