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May 31, 2022
CE versus FDA registration pathway for medical devices
Before medical devices may be sold in the EU or the US, they first need to be registered under the CE or FDA mark accordingly.
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April 28, 2022
The advantages of an AI/ML-enabled search engine for FDA records
The FDA’s new list of artificial intelligence and machine learning-enabled devices highlights opportunity for improvement.
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March 14, 2022
How EUDAMED will affect medical device manufacturers
EUDAMED provides a living picture of the lifecycle of medical devices
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March 14, 2022
SaMD - Software as a Medical Device - The Quick Guide
Software as a medical device is attracting attention in the MedTech communities
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March 14, 2022
Key implementation challenges of the Medical Device Regulation (MDR)
Major implementation challenges faces EU's MDR
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