+7 8412 20-58-24
Penza, 1B Centralnaya str., building 2
Penza, 1B Centralnaya str., building 2
QUALITY MANAGEMENT
SYSTEM
QUALITY MANAGEMENT SYSTEM
STABILITY OF PRODUCT QUALITY
The company's quality policy is aimed at ensuring that competitive medical devices are delivered on time and meet or exceed the requirements of contracts, national and international standards and norms that satisfy the consumer in terms of quality, reliability and safety.
The company's products have all the necessary permits. The implemented and functioning quality management system of the enterprise is certified for compliance with the requirements of the Russian standards GOST R ISO 9001-2015 (ISO 9001:2015) and GOST ISO 13485-2011 (ISO 13485:2003). In addition, the company is a part of the quality management system certified according to the requirements of the international standard EN ISO 13485:2012 of the Production Association "MedIndz". The annual audit is conducted by the British notified body "BSI Group".
The company's products have all the necessary permits. The implemented and functioning quality management system of the enterprise is certified for compliance with the requirements of the Russian standards GOST R ISO 9001-2015 (ISO 9001:2015) and GOST ISO 13485-2011 (ISO 13485:2003). In addition, the company is a part of the quality management system certified according to the requirements of the international standard EN ISO 13485:2012 of the Production Association "MedIndz". The annual audit is conducted by the British notified body "BSI Group".
INCREASING CUSTOMER SATISFACTION
Over the years, the company has developed a culture of production, the requirements for which were initially transferred to the parent company. The requirements meet the highest standards and often exceed them, due to the increased risk to the patient's life of failure of any third-risk product.
The manufacturing conditions of implantable medical devices are certified for compliance with the requirements of the standards "Medical devices". Quality management system. "System requirements for regulatory purposes", "Quality management systems". More than a third of the company's employees are engaged in product quality control operations.
The manufacturing conditions of implantable medical devices are certified for compliance with the requirements of the standards "Medical devices". Quality management system. "System requirements for regulatory purposes", "Quality management systems". More than a third of the company's employees are engaged in product quality control operations.
STRICT VETERINARY CONTROL OF RAW MATERIALS
"Cardioplant" biomaterials are highly purified sterile tissues of pets that have passed strict veterinary control.
The company pays special attention to the control and quality of raw materials for the manufacture of medical devices. We cooperate with large slaughterhouses in Penza, Moscow, Rostov region and the Republic of Mordovia. All these enterprises also have a quality management system in place and functioning.
Each of the meat processing enterprises has signed a technical agreement on compliance with the requirements for the procedure for sampling raw materials in accordance with the requirements of the international standard ISO 22442 "Medical products using fabrics and their derivatives of animal origin. Control of selection, collection and processing". Raw materials are delivered to the production base by air or road transport in special insulated containers within a few hours.
The company pays special attention to the control and quality of raw materials for the manufacture of medical devices. We cooperate with large slaughterhouses in Penza, Moscow, Rostov region and the Republic of Mordovia. All these enterprises also have a quality management system in place and functioning.
Each of the meat processing enterprises has signed a technical agreement on compliance with the requirements for the procedure for sampling raw materials in accordance with the requirements of the international standard ISO 22442 "Medical products using fabrics and their derivatives of animal origin. Control of selection, collection and processing". Raw materials are delivered to the production base by air or road transport in special insulated containers within a few hours.