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FDA Clinical Decision Support Software Vs. EU’s Medical Device Regulation

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n follow-up to our colleagues recent post about the newly implemented Medical Device Regulation (“MDR”) in the European Union, this post will discuss some of the similarities between FDA’s Clinical Decision Support (“CDS”) Software Draft Guidance (together the “CDS Draft Guidance”) and the MDR. 

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FDA Clinical Decision Support Software Vs. EU’s Medical Device Regulation

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Life Sciences + Healthcare

FDA + Healthcare Regulatory and Compliance