The international standard ISO 13485 Medical devices – Quality management systems – Requirements for regulatory purposes specifies requirements for a quality management system, when an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet user requirements and applicable regulatory requirements. Such organizations may be involved in one or more phases of the life cycle, including the design and development, manufacture, storage and distribution, installation or servicing of the medical device, as well as the design and development or provision of related activities (eg technical support). This International Standard can also be used by suppliers or external parties who provide the product, including services related to the quality management system, which they provide to such organizations.

Implementation and certification according to EN ISO 13485:

• demonstrates commitment to the quality of medical products;
• improves the overall performance of the process;
• communication with the market and the possibility of accessing new customers and markets improves;
• efficiency increases and costs decrease;
• it is proven that safer and more effective medical devices are produced;
• familiarity with legal requirements and customer expectations is demonstrated;
• profits increase;
• competition increases;
• customer satisfaction increases;
• internal relations improve;
• international verification of good business practice is obtained;
• a framework is created for continuous process improvement