How ISO 13485 is different from ISO 9001 ?
ISO 13485 is a great quality management standard for the manufacturer of medical devices. The manufacturer of the medical devices must be able to provide evidence that the devices are consistently following the safety and quality standards performing as per the standard for the customers or patients in the hospitals. With the help of 13485 certification, you’ll be able to get an internationally recognized approach to meet the requirement of medical device production in the world market.
ISO 13485 is designed to be used in the combination with the ISO 9001 Quality Management System. With ISO 13485, you will be able to enhance the common framework for a quality management system which is usually defined by ISO 9001 through inciting details that commonly apply to the medical device manufacturers.
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