ISO 13485 Medical Device Quality Management System

What is the ISO 13485 Medical Device Quality Management System?

The ISO 13485 Medical Device Quality Management System is a standard established to document that products are safe and secure, and to demonstrate that they meet minimum health requirements. Since medical devices are devices with special characteristics, there is a common structure and understanding for all countries within and outside the European Union. The standards are intertwined with the CE marking applied to medical devices. By meeting the certification requirements, health compliance and sterilization requirements are also met, and in addition to the requirements of the ISO 9001 Certificate, the goals for the necessary and sufficient quality standards specifically for medical devices are achieved.

Benefit of the Quality Management System for Medical Devices to Sterilization Standards

With the certificate, a solution is also provided for the sterilization within the scope of the subject. It also includes standards for the specific conditions of such devices. The implementation of the ISO 13485 Medical Device Quality Management System also serves as a guide in determining the risk groups for such devices.

Compliance with Laws and Regulations is Also Ensured

The ISO 13485 Medical Device Quality Management System establishes standards for quality, similar to the ISO 9001 Certificate. It paves the way for the continuous development of devices and the technologies to be produced for them. Since medical devices are also under strict legal scrutiny, their production in compliance with laws and regulations is ensured.