ISO 13485 is an international standard for quality management systems specifically defined for medical devices. The implementation of ISO 13485 is crucial in ensuring the safety and effectiveness of the product to the extent that the European Union regulations for ensuring the quality of medical devices are aligned with this standard. Additionally, Active Implantable Medical Devices (AIMD), In Vitro Diagnostic (IVD) devices, and other medical devices follow this standard in line with the regulatory laws of other countries with significant regulatory authority in medical devices, such as Japan, Canada, and the United States.
The importance of ISO 13485 in the medical industry
ISO 13485 (Quality Management System in Medical Devices) focuses on a quality management system in the design, development, production, assembly, after-sales services, and distribution of various medical devices, and facilitates the process of obtaining the CE mark for exporting to Europe.
The purpose of implementing ISO 13485
Medical devices are extensively used in various healthcare settings. When medical devices are prepared or used improperly, they can create very dangerous situations for human health. It is crucial for these devices to be used correctly and maintained according to strict standards to ensure patient safety and effective treatment. Therefore, appropriate standards and criteria have been prepared for several devices.
ISO 9001 Quality Management Systems for Medical Devices, which takes its fundamental structure and dynamics from the ISO 13485 Quality Management System and is established on this system, is a specialized system for medical devices with various criteria.
The primary objective of the ISO 13485 system is to align the regulatory requirements in the production of medical devices and the provision of services with the standards of the Quality Management System.
Advantages of ISO 13845, medical equipment management system:
- Increasing access to world markets by obtaining ISO 13845 certification
- Review and improve processes throughout the organization
- Increase productivity, reduce costs and monitor supplier performance
- Reassuring customers about safer and more effective production of medical equipment
- Estimating legal requirements and customer expectations