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      • And more…
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      • Performance evaluation of IVDs
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      • FDA relevant documents
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February 2, 2024


Radio Equipment Directive (RED) for networked medical devices

By Mario KlessascheckFebruary 2, 2024Leave a comment

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

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The most frequently asked questions about the quality management system

By Prof. Dr. Christian JohnerFebruary 2, 2024Leave a comment

This 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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