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European CABs (Conformity Assessment Bodies) now a reality - but are they worth it

This article was originally published in Clinica

Executive Summary

Is it worth paying to be audited by a European inspector to the US FDA's medical device regulations, or is it better to wait for a free audit from FDA inspectors themselves? Although European audits to the US regulations may only total some E3,000 ($3,000), which option is best for manufacturers?

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