MEDICAL DEVICES — QUALITY MANAGEMENT SYSTEMS
It specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. Such organizations can be involved in one or more stages of the life-cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities.
ISO 13485 was written to help medical device manufacturers design quality management systems that establish and maintain the efficiency of their processes. This ensures the design, development, production, installation, and delivery of safe medical devices for intended use.
ISO 13485, Medical Devices – Quality Management System – Requirements for regulatory purposes, is an internationally recognized standard for organizations involved in the medical device industry. Companies use compliance with this standard to obtain certification of their quality management system