Quality Management
We offer our Customers guaranteed high quality at all joint operation stages:
• Project management aimed at rapid production start-up;
• Design solutions based on Customers’ wishes and meeting requirements of standards and norms applicable to medical products;
• Highly-efficient supply management and raw transactional and completion materials quality acceptance control;
• Modern production solutions, manufacturing in the confines of monitored clean room facilities;
• Strict control in the course of production process and comprehensive laboratory inspection of finished products;
• Global support, reliability and quality throughout products’ presence in the market.
Quality control system operates at all production stages: from design to finished products shipment and surveillance over incidents involving the goods on the market. Parameters of materials and operational procedures are under control of the laboratory fitted with all equipment necessary for research.
The company has a quality management system introduced and effective in accordance with requirements of international ISO 9001:2008 and ISO 13485:2003 standards. At present, the certification audit has been planned and the time designated for its conduct by mdcGmbH (Germany, Stuttgart), a firm widely recognized and respected in the area of medical device production operations QMS certification.
Product Quality Control
The output product quality is one of the fundamentals of our successful and long-term relations with company customers.
The confidence in the reliability of our operations results is reached owing to our personnel’s high qualification and regular training, comprehensive range of metrology support for manufacturing and laboratory, certification of equipment, procedures and processes used, mandatory equipment inspection and calibration, and product tests.
The manufacturing process quality control is exercised at all stages, from the acceptance of raw materials and supplies and until finished-product output:
1. Procurement of raw materials and supplies is only performed after the approval of the vendor based on the assessment thereof; in addition, we arrange the audit of vendors of raw materials, supplies and completion materials, if requested by the customer.
2. All raw materials and supplies have a specification developed and approved bilaterally. Any material which may affect the products’ quality negatively will not be permitted for further use, and is either utilized or returned to the vendor, as appropriate. The output product quality is monitored by quality engineers at all manufacturing stages. Sampling for chemical and microbiological analysis and arbitrage is performed at raw materials and supplies acceptance stage. Quality and quantity analysis is performed in accordance with the specification embracing all requirements made to raw materials, with a due account of manufacture and output product peculiarities. Microbiological purity analysis is performed in accordance with regulatory documents governing microbiological requirements. Transactional raw and completion materials quality acceptance control is not our choice only; it is our obligation to both raw material suppliers and to customers and consumers of our products!
3. The products undergo strict control in the course of manufacturing for the adherence to the reference specimen and specification, in terms of organoleptic, physicochemical and microbiological indicators. Semi-manufactured and finished products undergo various tests and analysis throughout the entire manufacturing cycle. The finished products are only output if all indicators are normal, and the products meet safety and quality requirements.
4. Finished products control does not end at this stage, it continues during the entire shelf life: specimens from each finished product output lot are stored at the arbitrage warehouse, and their control is exercised at certain time intervals.