ISO 13485:2003 an international standard designed to orient quality management systems toward the design, development, production, and installation of medical devices and related services.
Though based on ISO 9001, ISO 13485 is focused on meeting regulatory requirements, risk management and maintaining effective processes, namely the processes specific to the safe design, manufacture and distribution of medical devices.
ISO 13485 requires the risk management methodology to be thoroughly documented and conducted throughout a product’s entire lifecycle, from initial concept to delivery and post-delivery. However, the standard leaves the specifics to a related standard, ISO 14971, Application of Risk Management for Medical Devices.
ISO 13485:2003 an international standard designed to orient quality management systems toward the design, development, production, and installation of medical devices and related services. 
