EN ISO 13485:2016 is the established quality management standard for companies in the medical device industry. In conjunction with the EU Medical Device Regulations (MDR), EN ISO 13485:2016 specifies the requirements for a quality management system for medical device manufacturers. The standard places particular emphasis on the safety of medical devices manufactured. With EN ISO 13485:2016, companies that are not direct manufacturers of medical devices but are involved in various phases of the product life cycle now also can be certified.
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