Gepubliceerd op maandag 19 augustus 2013
“S” is for scope: does that include to ‘enhance’?
Medicaldeviceslegal.com: The scope of the concept of medical device is in constant flux. The EU amended the definition slightly in 2007 to accomodate for standalone software as medical device, the GHTF changed its definition not that long ago, and currently the EU is working on a new medical devices definition in the medical devices regulation proposal.
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