First CAB (conformity assessment body): How attractive will it be?
This article was originally published in Clinica
Executive Summary
The listing by the US FDA of a conformity assessment body (CAB) as part of the EU/US MRA means that for first time manufacturers in Europe can go to a "local" testing and certification organisation to have their products tested against US requirements. In theory, no more will be needed than the US FDA's final approval.
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