Quality Management System
Мanufacture and quality system
The main focus of the enterprise is on the quality and safety of manufactured products which are ensured by the presence of a certified and constantly improved Quality Management System, modern technologies and equipment, and highly qualified personnel. The products of the enterprise of 1, 2 and 3 classes of potential risk of use according to the classification of Directive 93/42 EEC are manufactured in controlled conditions of clean rooms with modern high-performance equipment from leading European manufacturers - these are injection molding machines and extruders, cytobrush machines, packaging, winding, filling machines, etc.
The raw materials and semi-finished products from qualified and reliable suppliers with certified quality management systems are used during the manufacture. All materials undergo careful incoming quality and safety control. The quality of manufactured products is ensured by compliance with production, packaging and storage technology. The validated process of final radiation, gas and plasma sterilization is carried out at modern certified equipment.
Product quality management is based on constant customer orientation with mandatory compliance with product safety requirements. The employees of the company continuously monitor manufactured products and collect proposals for their improvement. This information is the basis for the process of designing and developing new products, upgrading serially manufactured products. Product development and improvement is also based on the analysis of global trends in the development of medical products market, on our own scientific research work conducted jointly with leading clinics, on marketing and patent research.
New products are created using computer-aided design systems, undergo safety testing and clinical evaluation in the 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. The company is certified for compliance with the requirements of ISO 13485:2016. The products of the company are certified for compliance with EU requirements and have a CE mark. Since 2018, we have been consistently implementing a lean manufacturing system and the principles of KAIZEN philosophy.
Certificate
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