Directive 2014/53/EU (Radio Equipment Directive (RED)) applies to devices that use Wi-Fi or RFID, for example. Medical devices that send a radio signal because they connect to the internet or are operated remotely also need to demonstrate conformity with the RED before being marketed. In this article, learn more about
DetailsThis FAQ provides answers to the most common questions that companies such as medical device manufacturers have about quality management systems (QM systems) and ISO 13485.
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