ISO 13485: 2016 is an international standard created for companies engaged in the procurement of materials, design, development, production, installation, service, and sale of medical products. It includes requirements for a quality management system where organizations need to demonstrate their ability and responsibility above all, that medical devices and related services are in line with customer requirements and prescribed standards.
The quality management system for medical devices (ISO 13485: 2016) is based on the requirements of the Quality Management System (ISO 9001: 2015) standard and thus complementary, which makes it easy to implement into the system for organizations that already have ISO 9001.
The company Denta BP Pharm from Belgrade, which distributes pharmaceutical devices, recognized the importance of this standard and with the help of Mobes Group implemented it in its system to improve the quality of its business, provide better process control, and position itself on the market as a leader in its industry.
By meeting the requirements of the ISO 13485: 2016 standard, the company proves that it applies the best practice in terms of the quality of its medical devices and associates have a guarantee that the given products meet high-quality standards that are recognized worldwide.
