ISO 13485 QUALITY MANAGEMENT SYSTEM FOR MEDICAL DEVICES

ISO 13485, Medical devices -- Quality management systems -- Requirements for regulatory purposes is an International Organization for Standardization (ISO) standard published for the first time in 1996; it represents the requirements for a comprehensive quality management system for the design and manufacture of medical devices.The ISO 13485 Certificate ensures the continuity of the ability to determine and meet the customer demands for each company operating in the operational processes such as production, sale and procurement of medical devices. It ensure the customer confidence on the fact that the products are manufactured in a system that is safe for human health in all phases such as beginning from raw materials to design, production, storing and shipment.

Adopting ISO 13485 provides a practical foundation for manufacturers to address the EU Medical Device Directive (MDD), the EU Medical Device Regulation (MDR), and other regulations, as well as demonstrating a commitment to the safety and quality of medical devices. The ISO 13485 Certificate is required for manufacturers of medical devices to meet the legal requirements and to obtain CE Mark.

To meet the legal requirements and to obtain CE Mark, it is necessary for manufacturers to get the certifications of ISO 13485.