ISO 13485 - QUALITY MANAGEMENT SYSTEM OF MEDICAL PRODUCTS
The accredited ISO 13485 certificate creates global recognition and reputation for companies in the medical sector, including manufacturers, suppliers, suppliers of semi-finished products and services for storage. SZUTEST Ukraine, the authorized body of NB, provides accredited certification of ISO 13485: 2016 quality management system for medical devices. Services. - medical quality management system with its experienced staff.
The modern health care system relies on health technology and human resources. Medical devices, one aspect of health technology, provide healthcare providers with the tools to efficiently and effectively perform their functions. Although medical devices provide an opportunity for better service, the lack of a national system of selection, procurement, use and management can lead to a disproportionate increase in the cost of medical care. Member States need to create systems for standardizing and regulating the selection, procurement, use and management of these tools.
The majority of the world's population does not have adequate, safe and reliable access to appropriate medical devices within their health care systems. The situation in the region is difficult to assess, given the existing gaps in knowledge and the lack of data. However, some studies point to a number of problems associated with the management of medical devices, while the regional market for medical devices is growing. Without proper demand management, by assessing actual needs, adequate procurement, proper installation, preventive maintenance, rational use and quality assurance, it will be difficult for health care providers to contain rising costs.
ISO 13485 specifies requirements for a quality management system, in which an organization must demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services.
Regulators in most major markets (including the European Union, USA, Canada, Japan, and Taiwan) require or strongly prefer manufacturers selling medical products in their countries to have a proven and certified third party quality management system. A system compliant with ISO 13485 speeds up access to those countries that need it.
In some markets, medical device distributors must also comply with regulatory requirements. That is why these distributors prefer to implement a quality management system corresponding to 13485.
SZUTEST is accredited by the Turkish Accreditation Agency (member of EA) and IAS under ISO 13485 in accordance with EN ISO 17021.