More Notified Bodies Give Up on EU MDR/IVD Certification

The shortage of notified bodies to certify devices for the new EU medical device and IVD regulations appears to be reaching crisis point as more notified bodies say they won’t be offering certification. Read More

Devicemakers Comment on FDA’s Approach to Machine Learning for SaMD

A combination of real-world evidence and periodic reporting to the FDA should be the cornerstone of how the agency regulates AI and machine learning in software… Read More

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