Iso 13485 200311/28/2023 ![]() The implementation of ISO 13485 is a requirement of the legislation (National legislation, Ministry Decision 1348/2004 / Government Gazette 32B '). It concerns companies that design and produce medical devices, that market medical devices, that install and provide technical support for medical devices. ISO 13485: 2003 is a standard that sets out the steps required to implement a medical device management system.
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